FDA Roundup of the Week: October 28

Catch up on all the past week's action in US Food and Drug Administration rulings and decisions.

MD Magazine's typical coverage expanded a bit more this week. A series of US Food and Drug Administration (FDA) decisions on rare diseases and conditions came nearly in day-by-day succession. Though the common rate of approvals, response letters, and other designations was on par, the therapies to receive federal decision this week were typically far from ordinary.

FDA Rejects Xyosted for Hypogonadism

Shingrix Gets FDA Go-Ahead

FDA Approves Soliris for Generalized Myasthenia Gravis

FDA Approves Once-Weekly Bydureon BCise for Type-2 Diabetes

FDA Fast-Tracks Possible Alzheimer's Modifier

GOCOVRI for Dyskinesia Gets Orphan Drug Designation

FDA Requests More Trial Data for Translarna for DMD

FDA Generic Approvals Are Rising Without Plans to Stop

FDA Grants Priority Review to Elagolix

New Uterine Fibroids Oral Treatment Could Replace Surgery

Catch up on all the news with the FDA Roundup of the Week!Antares Pharma’s QuickShot Testosterone auto injector for low testosterone levels associated with hypogonadism in adult males was rejected, with expressed concerns that it could cause meaningful blood pressure increase, as well as depression and suicidality occurrences.The drug's approval follows a unanimous positive opinion from the Vaccines and Related Biological Products advisory committee on Sept 13, and preceded a Center for Disease Control & Prevention advisory board’s recommendation that it become the primary shingles vaccine.The new gMG therapy for patients who are acetylcholine receptor antibody-positive is an intravenous monoclonal antibody that has been previously approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.The exenatide extended-release injectable suspension will help T2D adult patients improve glycemic control through a once-weekly, single dose that helps reach and maintain a steady state.ALZ-801 from Alzheon has reported novel ability to block the formation of toxic amyloid oligomers, a possible agent of Alzheimer’s disease development and progression. A Phase 3 trial under the fast track will hone in on Alzheimer’s patients homozygous for the E-4 allele of apolipoprotein E genotype.The FDA designated a 7-year orphan drug exclusivity for the extended-release 274 mg amantadine capsules — the only FDA-approved therapy for dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy. The designation will run through August 24, 2024.PTC Therapeutics’ investigational ataluren (Translarna) was flagged by the FDA for a lack of effectiveness evidenced in clinical trials, as well as “other nonclinical and CMC matters.” Stuart W. Pelts, PhD, PTC chief executive officer, expressed intention to file a formal dispute resolution request with the administration.According to the most recent FDA data, the administration approved 763 generic drugs in the 2017 fiscal year, an 18.7% boost from the previous fiscal year (651), and is the highest annual rate since the FDA began recording the data under the Generic Drug User Fee Amendments in 2012. The approval count is nearly double that of the 2013 fiscal year total (409). In fact, generic approvals exceeded the 2013 rate just midway through the 2017 fiscal year.The orally-administered gonadotropin-releasing hormone could provided significant improvements in the safety and efficacy of endometriosis therapy, while becoming the first oral treatment option for endometriosis-associated pain in more than a decade.Ulipristal acetate was approved for treating abnormal bleeding in women with uterine fibroids, years after hitting European and Canadian markets. The first oral treatment could hit the market as soon as next summer.