What You Missed From The FDA Last Week—August 18-22, 2014

Biogen Idec Awarded Approval For Plegridy

The FDA approved Biogen Idec’s injectable drug, Plegridy, for relapsing-remitting multiple sclerosis. It will be entering Biogen Idec’s MS portfolio with the company’s first MS drug, Avonex, which will still remain in the market. However, Plegridy contains the polyethylene glycol, or peg, polymer which cuts down on the frequency of doses patients need to take. The drug is injected into muscle every two weeks, compared to Avonex which needs to be taken once every week. Plegridy was recently approved by the European Commission to be sold in 28 countries.

Lilly and Boehringer Ingelheim Granted Approval For Basaglar

Should litigation by Sanofi come out in favor of Eli Lilly and Boehringer Ingelheim, patients with type 2 diabetes will have access to the currently-tentatively approved insulin glargine injection Basaglar. The drug is indicated for adults with type 2 diabetes and can be taken in combination with mealtime insulin for adult and pediatric patients with type 1 diabetes. The approval was partially based on reports from the companies’ clinical program, including data from phase 3 studies investigating the drug’s effect in people with both type 1 and type 2 diabetes. 

Genzyme’s Gaucher Drug Given Green Light

Genzyme’s Cerdelga for Gaucher disease was given a nod of approval by the FDA last week. The experimental capsule is expected to be on the market within the next month, and it could potentially become the prime seller to treat those suffering from Gaucher disease. This drug joins Genzyme’s portfolio with Cerezyme, an injectable Gaucher drug treatment that replaces an enzyme deficiency. Cerdelga is a substrate inhibitor, which slows production of glucosylceramide synthase. The company will keep Cerezyme on the market, however it expects that the convenience of taking the Cerdelga in pill form twice a day will win the favor of patients undergoing Cerezyme’s two-hour infusions every two weeks. The company has not yet designated the drug’s price.

New Type 1 Diabetes Autoantibody Test Granted Approval

KRONUS Market Development Associates was awarded approval for its KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay. This assay will help determine if a person has type 1 diabetes specifically, rather than another type of diabetes, and could play a key role in ensuring proper and prompt treatment is granted to those in need. Those with type 1 diabetes often produce ZnT8Ab, which is not found in patients with type 2 and gestational diabetes.  This new assay detects the ZnT8 autoantibody in a patient’s blood. The assay was investigated in a clinical study the comprised 569 blood samples and detected the autoantibody in 65 percent of patients diagnosed with type 1 diabetes.

FDA Awards Approval To GSK Asthma Drug

Arnuity Ellipta (fluticasone furoate inhalation powder) was granted approval for the treatment of those 12 and up suffering from asthma. The drug is a once-daily inhaled corticosteroid (ICS) medicine that is approved in two doses: 100mcg and 200mcg. Patients receive the drug via the dry powder inhaler Ellipta — a current staple in GSK’s respiratory portfolio. The drug proved its safety and efficacy in more than 3,600 patients with asthma.

Eliquis Approved For DVT, PE

Eliquis, a blood-clot prevention drug from Bristol-Myers Squibb and Pfizer, received approval to treat blood clots in the legs and lungs—characteristics of deep vein thrombosis and pulmonary embolism, respectively. Eliquis is responsible for blocking the Factor Xa protein that plays a major role in the clotting process. The drug is already approved to prevent stroke in patients that have atrial fibrillation. In the AMPLIFY study, the drug was found to be comparable to currently standard of care enoxaparin/warfarin  in DVT and PE patients.

Pharma Talking points

In the latest chapter on the biosimilar naming debate, the Wall Street Journal blog reports that physician groups have jumped on the wagon with Big Pharma about how biosimilar drugs should be named. In a letter sent to the FDA, 10 medical societies and a physicians’ group argued that a biosimilar should have a different name than that of the brand-name biologic because it will be easier for prescribers to distinguish between medicines and track adverse events and side effects in patients.

A Venture Beat article discusses a recent speech made by Genetech CEO Ian Clark who focused on the emergence of consumer-driven healthcare and the individual’s access to his or her own personal genome. While Clark believes this is the patient’s right to access his/her own genome to manage physical well-being, he also argues that, since genome-reading services are new for the FDA, the agency will need additional funding in order to ensure that genome-reading services are performed correctly and patient safety remains intact.