FDA News Roundup: Biogen Idec, GSK, Roche, And More

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Orphan Drug Designations:

Co-D Therapeutics Triolimus — a treatment regimen comprising paclitaxel, rapamycin, and tanespimycin — was named an orphan drug for angiosarcoma.

Retrophin has earned orphan designation for its RE-024 indicated for pantothenate kinase-associated neurodegeneration. Patients are currently being screened for participation in a Phase 1 safety study.  

AbbVie, Biogen Zinbryta BLA Accepted For Review

The FDA is set to review the Biologics License Application for the monoclonal antibody Zinbryta for relapsing forms of multiple sclerosis. Supporting the application were results from the DECIDE and SELECT studies, in which relapsing-remitting MS patients received 150 mg of Zinbryta for a month. The treatment is currently being evaluated for marketing approval in the European Union.

Vernalis, Tris XR Cough Treatment Wins Approval

The two companies’ got a nod from the FDA for their NDA for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III). Indicated for the treatment of coughing and other respiratory allergy or cold symptoms, the treatment is currently the only cold treatment containing codeine to hit the market.

Breo Ellipta Approved For Asthma Treatment

GSK and Theravance got the green light for their Breo Ellipta once-daily asthma treatment for adults. The fixed-dose combination of fluticasone furoate and vilanterol is available in two strengths: 100/25 mcg and 200/25 mcg. The drug is administered via the Ellipta dry powder inhaler. The company also sought approval for the treatment’s use in patients age 12 to 17, however the FDA issued a Complete Response Letter (CRL), requesting more data before opening up the treatment for this age group. Breo Ellipta was examined in 12,000 subjects ages 12 and up in 23 studies.

Medicines Co. Blood-Clotting Agent Approved

The FDA approved the homeostatic product Raplixa, a combination of fibrinogen and thrombin—two human plasma-derived blood-clotting proteins. The dry powder formulation, approved for use with a gelatin sponge, is indicated to stop bleeding during surgery when other blood-clotting agents fail. According to Reuters, analysts expect the drug to bring in $100 million in the U.S.  

Amerigen Given Tentative Nod For Toviaz

The company’s Abbreviated New Drug Application (ANDA) for its generic of Toviaz received a tentative approval from the FDA. The Pfizer-marketed brand name drug Toviaz (Fesoterodine Fumarate Extended-release tablets, 4mg and 8mg) is indicated to decrease the symptoms of overactive bladder. Toviaz raked in $215 million for fiscal year 2014. Amerigen is currently attempting to challenge some of the existing patents in place for Toviaz, with a trial expected to launch in July of this year.

Glenmark Generic Given Tentative Nod

Glenmark’s calcipotriene cream, indicated for plaque psoriasis, received tentative approval from the FDA as a generic for Donovex Cream 0.005 percent. Patents for Donovex — a treatment which earned roughly $93 million in the previous fiscal year — are set to expire in early June.

Emergent BioSolutions Ixinity Wins Approval

The intravenous, hemophilia B treatment, Ixinity (coagulation factor IX (recombinant)), won approval to control and prevent bleeding episodes and for perioperative management in children and adults age 12 and up. In a Phase 1/3 clinical trial, the treatment demonstrated efficacy as routine or on-demand treatment comparable to that of nonacog alfa, another recombinant coagulation factor IX product.

Ventoclax Awarded Breakthrough Designation

AbbVie, Genentech, and Roche’s chronic lymphocytic leukemia treatment venetoclax received breakthrough therapy designation. The candidate is currently indicated for previously-treated patients that possess the 17p deletion. Those with 17p deletion account for 3 to 10 percent of all CLL patients and 30 to 50 percent of relapsed/refractory CLL patients, and often face less than 2 years of life expectancy.