Drug and Device News

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Verzenio for Breast Cancer

The FDA has approved abemaciclib (Verzenio, Eli Lilly and Co.) to treat adults with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced or metastatic breast cancer that has progressed after endocrine therapy.

Abemaciclib is indicated in combination with the endocrine therapy fulvestrant (Faslodex, AstraZeneca) after cancer has progressed on endocrine therapy. It is also indicated on its own for patients who were previously treated with endocrine therapy and chemotherapy after the cancer had metastasized.

The safety and efficacy of abemaciclib in combination with fulvestrant were studied in a randomized trial of 669 patients with HR+, HER2− breast cancer that had progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized. Median progression-free survival with abemaciclib and fulvestrant was 16.4 months, compared with 9.3 months for placebo and fulvestrant.

The safety and efficacy of abemaciclib as a stand-alone treatment were studied in a single-arm trial of 132 patients with HR+, HER2− breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized. The objective response rate was 19.7% in patients taking abemaciclib, lasting for a median 8.6 months.

Source: FDA, September 28, 2017

Fiasp Mealtime Insulin

A fast-acting mealtime form of insulin aspart injection, 100 units/mL (Fiasp, Novo Nordisk), has received FDA approval to improve glycemic control in adults with type-1 and type-2 diabetes.

Fiasp can be dosed at the beginning of a meal or within 20 minutes after starting a meal. It is a new formulation of Novo-Log, with niacinamide (vitamin B3) added to help increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes. Fiasp will be available in a prefilled delivery device (FlexTouch pen) and a 10-mL vial, and will launch at the same list price as NovoLog.

The approval of Fiasp is based on results from the onset phase 3a clinical development program. The clinical trials enrolled more than 2,000 adults with type-1 and type-2 diabetes to evaluate the efficacy and safety of Fiasp administered both at mealtime and after starting a meal. Data from the trials showed that Fiasp demonstrated a reduction in hemoglobin A1c in adults with type-1 and type-2 diabetes.

Source: Novo Nordisk, September 29, 2017

Mylotarg for AML

The FDA has approved gemtuzumab ozogamicin (Mylotarg, Pfizer) to treat adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug is also approved for patients 2 years of age and older with CD33-positive AML who have relapsed or have not responded to initial treatment.

Gemtuzumab received accelerated approval in May 2000 as a stand-alone treatment for older patients with CD33-positive AML who had experienced a relapse, but it was withdrawn from the market in 2010 after confirmatory trials failed to verify clinical benefit and demonstrated safety concerns. The new approval includes a lower recommended dose, a different dosing schedule, and a new patient population. The FDA said careful review of the new regimen showed that its benefits outweigh its risks.

The safety and efficacy of gemtuzumab in combination with chemotherapy were studied in 271 adults with newly diagnosed CD33-positive AML who were randomized to receive gemtuzumab with daunorubicin and cytarabine or to receive daunorubicin and cytarabine alone. The trial measured event-free survival from the date patients started the trial. Patients who received gemtuzumab with chemotherapy went longer without complications than those who received chemotherapy alone (median event-free survival, 17.3 months versus 9.5 months).

The safety and efficacy of gemtuzumab monotherapy were studied in two trials. The first included 237 patients with newly diagnosed AML who could not tolerate or chose not to receive intensive chemotherapy. Patients were randomized to receive treatment with gemtuzumab or best supportive care. Patients who received gemtuzumab had a median overall survival of 4.9 months versus 3.6 months for best supportive care. The second trial, a single-arm study, included 57 patients with CD33-positive AML who had experienced one relapse. Patients received a single course of gemtuzumab; afterward, 26% achieved a complete remission that lasted a median 11.6 months.

The prescribing information for gemtuzumab includes a boxed warning that severe or fatal hepatotoxicity occurred in some patients who took the drug.

Source: FDA, September 1, 2017

Mvasi, First Cancer Biosimilar

The FDA has approved bevacizumabawwb (Mvasi, Amgen/Allergan) as a biosimilar to bevacizumab (Avastin, Genentech) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for cancer treatment.

Bevacizumab-awwb is approved for the treatment of certain colorectal, lung, brain, kidney, and cervical cancers. The FDA’s approval was based on review of extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It was approved as a biosimilar, not an interchangeable product.

Like Avastin, the labeling for Mvasi contains a boxed warning about an increased risk of gastrointestinal perforations; surgery and wound-healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal hemorrhage.

Source: FDA, September 14, 2017

Aliqopa for Relapsed Follicular Lymphoma

The FDA has granted accelerated approval to copanlisib (Aliqopa, Bayer Healthcare Pharmaceuticals) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.

The approval of copanlisib was based on a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin’s lymphoma who had relapsed disease following at least two prior treatments. The trial measured the overall response rate; 59% of patients had a complete or partial response for a median of 12.2 months.

Serious side effects include infections, hyperglycemia, hypertension, noninfectious pneumonitis, neutropenia, and severe skin reactions.

Source: FDA, September 14, 2017

Trelegy Ellipta for COPD

The FDA has approved once-daily, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol (Trelegy Ellipta, GlaxoSmith-Kline/Innoviva, Inc.) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease.

This includes patients with chronic bronchitis and/or emphysema who are on a fixed-dose combination of fluticasone furoate (FF), an inhaled corticosteroid, and vilanterol (VI), a long-acting beta2-adrenergic agonist, for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired. It also includes patients who are already receiving the long-acting muscarinic antagonist umeclidinium (UMEC) and a fixed-dose combination of FF/VI. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.

The FDA-approved strength of FF/UMEC/VI is 100/62.5/25 mcg, delivered once daily in GlaxoSmithKline’s Ellipta dry powder inhaler.

Source: GlaxoSmithKline, September 18, 2017

Xhance Nasal Spray

Fluticasone propionate nasal spray (Xhance, Optinose) has received FDA approval for the treatment of nasal polyps in patients 18 years of age and older. The 93-mcg intranasal spray is designed to reach targeted areas deep in the nose with a new exhalation delivery system. The drug is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device.

In phase 3 trials, patients using the spray experienced statistically significant reductions of both nasal congestion and obstruction, as well as total polyp grade.

Source: Optinose, September 18, 2017

Solosec for Bacterial Vaginosis

The FDA has approved secnidazole 2 g oral granules (Solosec, Symbiomix Therapeutics) for the treatment of bacterial vaginosis (BV) in adults. Secnidazole, a next-generation, 5-nitroimidazole antibiotic, is the first single-dose oral therapy for BV and the first new oral antibiotic to treat BV in more than a decade.

Support for the FDA approval included two pivotal trials in BV and an open label safety study. All treatment-emergent adverse events were mild or moderate, and no patients discontinued treatment due to adverse events.

Source: Symbiomix Therapeutics, September 18, 2017

Generic Approvals

Isoproterenol Hydrochloride Injection

The FDA has approved the first generic version of isoproterenol hydrochloride injection (Isuprel, Valeant), a medication that helped fuel debate over costs when Valeant raised the price more than 300% after buying the six-decade-old drug in 2015.

Nexus Pharmaceuticals’ isoproterenol injection, which received expedited review, is available as a single-dose vial containing 0.2 mg/1 mL or 1 mg/5 mL. The drug (first approved in 1956) is used to treat mild or transient episodes of heart block that do not require electric shock or pacemaker therapy; serious episodes of heart block and Adams-Stokes attacks; congestive heart failure; cardiogenic shock; and other serious issues.

Sources: FDA, August 8, 2017; Nexus Pharmaceuticals, August 3, 2017; and FiercePharma, August 7, 2017

Oseltamivir Phosphate For Oral Suspension

Oseltamivir phosphate for oral suspension, 6 mg (base)/mL (Nesher Pharmaceuticals), the generic form of Tamiflu (Roche), has been approved by the FDA. The drug is used to treat influenza A and B in patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours, and to prevent flu in patients 1 year of age and older.

Source: Nesher Pharmaceuticals, September 14, 2017

Tacrolimus Injection

Hospira, Inc., has received approval to market tacrolimus injection in 5-mg/mL, 1-mL single-dose vials. This is the generic version of Astellas’ Prograf, used for prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants.

Source: Hospira, August 25, 2017

Ephedrine Sulfate Injection

Sandoz has received approval for ephedrine sulfate injection USP, 50 mg/mL single-dose vial. This is the generic form of Akovaz (Flamel Ireland), used in the treatment of clinically important hypotension related to anesthesia.

Source: Sandoz, August 23, 2017

Lanthanum Carbonate Chewable Tablets

The FDA has approved Natco Pharma’s application for lanthanum carbonate chewable tablets, the generic form of Fosrenol (Shire), used to reduce serum phosphate in patients with end-stage renal disease. The tablets come in 500-mg, 750-mg, and 1000-mg base doses.

Source: Natco Pharma, August 11, 2017

NEW INDICATIONS

Opdivo for Liver Cancer

The FDA has approved nivolumab injection for intravenous use (Opdivo, Bristol-Myers Squibb) for the treatment of patients with hepatocellular carcinoma (HCC) who have been treated previously with sorafenib (Nexavar, Bayer Healthcare).

This indication received accelerated approval based on tumor response rate and durability of response. In the CheckMate-040 trial, 14.3% of HCC patients responded to treatment with nivolumab. Among the 22 responders, responses ranged from 3.2 to 38.2-plus months.

Most HCC patients are diagnosed with advanced-stage disease and have limited treatment options.

Source: Bristol-Myers Squibb, September 22, 2017

Keytruda for Stomach Cancer

Pembrolizumab (Keytruda, Merck) has received FDA approval to treat certain patients with recurrent locally advanced or metastatic gastric or gastro esophageal junction adenocarcinoma.

The new indication covers patients whose tumors express programmed death ligand-1 with a combined positive score of at least one as determined by an FDA-approved test and who exhibit disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.

This indication received accelerated approval based on tumor response rate and durability of response. The KEYNOTE-059 trial included 143 patients similar to the population covered in the new indication. Their objective response rate was 13.3%; among the 19 responding patients, the duration of response ranged from 2.8-plus to 19.4-plus months.

Source: Merck, September 22, 2017

Tracleer for Pediatric PAH

The FDA has approved a new 32-mg tablet for oral suspension for bosentan (Tracleer, Actelion Pharmaceuticals US, Inc.) for use in patients 3 years of age and older with idiopathic or congenital pulmonary arterial hypertension (PAH) to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. Bosentan becomes the first FDA-approved medicine for U.S. children with PAH.

Bosentan is an orally active endothelin receptor antagonist. The 32-mg scored tablet can be dispersed in a teaspoon of water before oral administration. The lower dosage and score lines on the tablets are designed to allow physicians to vary the prescribed dose by patient weight.

Source: Actelion Pharmaceuticals US, Inc., September 6, 2017

Privagen for CIDP

Immune globulin intravenous (human), 10% liquid (Privigen, CSL Behring), has received FDA approval for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. CIDP is a rare autoimmune disorder that affects the peripheral nerves.

The biologic was initially approved to treat primary immunodeficiency and chronic immune thrombocytopenic purpura in 2007. The approval for CIDP was based on two phase 3 clinical studies. In the PATH study, 73% of the 207 patients receiving Privigen responded over the 13-week course of treatment, as measured by adjusted scores on the Inflammatory Neuropathy Cause and Treatment (INCAT) scale. In the PRIMA study (n = 28), 61% of patients responded to Privigen over 25 weeks as measured by adjusted INCAT scores.

The prescribing information for Privigen includes a boxed warning for thrombosis, renal dysfunction, and acute renal failure.

Sources: CSL Behring and FDA, September 14, 2017

Dotarem for Younger Patients

The FDA has approved gadoterate meglumine (Dotarem, Guerbet LLC USA) for intravenous use with magnetic resonance imaging in patients younger than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood–brain barrier and/or abnormal vascularity of the central nervous system. It was previously approved for this use in patients older than 2 years of age.

The FDA’s review was based on a study showing that at the standard dose (0.1 mmol/kg), the pharmacokinetic and safety profiles in pediatric patients younger than 2 years were similar to those of older children and adults.

Source: Guerbet LLC USA, September 5, 2017

Austedo for Tardive Dyskinesia

Deutetrabenazine (Austedo, Teva Pharmaceutical Industries) is now indicated for the treatment of tardive dyskinesia in adults.

The FDA’s approval was based on results from two phase 3, randomized, double-blind, placebo-controlled, parallel-group studies assessing the efficacy and safety of deutetrabenazine in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia.

Deutetrabenazine was previously approved for the treatment of chorea associated with Huntington’s disease (HD) in April 2017. The drug carries a boxed warning: It can increase the risk of depression and suicidality in patients with HD.

Source: Teva, August 30, 2017

Somatuline Depot For Carcinoid Syndrome

Lanreotide injection 120 mg (Somatuline Depot, Ipsen Biopharmaceuticals, Inc.) has received FDA approval for the treatment of carcinoid syndrome. When used, it reduces the frequency of rescue therapy with a short-acting somatostatin analogue (SSA).

Lanreotide depot, an SSA, is also approved for the improvement of progression-free survival in patients with unresectable, well- or moderately differentiated, locally advanced, or metastatic gastroentero-pancreatic neuroendocrine tumors.

The approval for carcinoid syndrome was based on a 16-week, randomized, double-blind, phase 3 trial. Patients randomized to lanreotide depot/autogel every four weeks needed short-acting octreotide as rescue medication on an adjusted mean of 33.7% of days, compared with 48.5% for placebo.

Sources: Ipsen, September 18, 2017; and Endocrine Practice, September 2016

Aptiom for POS in Children

The FDA has expanded the indication for eslicarbazepine acetate (Aptiom, Sunovion) to include treatment of partial-onset seizures (POS) in children and adolescents 4 to 17 years of age. Eslicarbazepine, administered as a once-daily, immediate-release tablet, is also approved for POS treatment in adults.

The new approval is based on FDA guidance that permits the extrapolation of data to support pediatric use. The safety and efficacy of eslicarbazepine as monotherapy and adjunctive therapy for the treatment of POS in adults were established in five clinical trials. Data from three clinical trials conducted by Sunovion’s partner BIAL, a Portuguese pharmaceutical company, also supported the safety and tolerability of eslicarbazepine for the treatment of POS in pediatric patients. Pharmacokinetic analyses of adult and pediatric data supported the proposed dosing regimen in the pediatric population.

Source: Sunovion, September 14, 2017

Afluria Quadrivalent Flu Vaccine for Age 5 and Up

The FDA has approved Afluria Quadrivalent influenza vaccine (Seqirus) for use in people 5 years of age and older. The vaccine was first approved in August 2016 for people 18 years of age and older to help protect against two influenza A-strain viruses and two B-strain viruses. The traditional seasonal flu vaccine protects against two A strains and a single B strain.

Both Afluria and Afluria Quadrivalent are now licensed and recommended for ages 5 years and up. Both have a needle-free injection delivery option for people ages 18 to 64 years.

In clinical trials, Afluria Quadrivalent demonstrated noninferiority to comparators for all influenza strains contained in the vaccine.

Source: Seqirus, September 14, 2017

 

Continue at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5642153/

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