January’s Potential Budget Busting Approvals and more.....

There are two investigational drugs with January 2019 PDUFA dates. We note two drugs scheduled for January reviews and highlight drug development for Alzheimer’s. 

Immunomedics, Seattle Genetics’ sacituzumab govitecan has a PDUFA date of January 18th. It is an antibody-drug conjugate targeting triple-negative breast cancer. Immunomedics is seeking approval for the treatment of metastatic triple-negative breast cancer in patients that have previously received at least two prior therapies for metastatic disease. 

Alkermes’ samidorphan buprenorphine has a PDUFA date of January 31st. The drug has a Fast Track priority designation. However, The FDAs Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Committee voted 21-2 against recommending approval of buprenorphine/samidorphan in a joint meeting in November 2018. The committee felt that efficacy had not been proven and studies had methodological problems, but in a narrow vote (13-10) indicated that safety had been demonstrated.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review Lexicon Pharmaceuticals/Sanofi’s sotagliflozin in mid-January. The drug is a SGLT inhibitor for the treatment of type 2 Diabetes with a PDUFA Date of March 22,2019, and no Priority Designations.

The FDA's Reproductive and Urologic Drugs Advisory Committee review romosozumab in mid-January. Romosozumab is a monoclonal antibody investigational drug for the treatment of osteoporosis by inhibiting the action of sclerostin. On July 17th, 2017, the FDA rejected romosozumab. This decision was expected because of the higher rate of serious adverse cardiovascular events when compared with alendronate. Amgen and UCB refiled an NDA for romosozumab in July 2018.

As we highlighted in our weekly update on January 8th, Evaluate.com’s Vantage 2019 Preview noted that a potentially very valuable but elusive therapy area for 2019 is Alzheimer’s disease, and this year will undoubtedly contain updates. We list 23 investigational drugs for Alzheimer's disease in our knowledgebase. None of the drugs have 2019 PDUFA Dates. 

It has been debated whether potential treatments would be more effective if used before development of symptoms in Alzheimer's Disease.  Studies in early stages of the disease have not been successful, so the drugs may need to be tested in patients at risk of developing the disease. To address this issue, the FDA has proposed that if reliable biomarkers can be developed to diagnose Alzheimer’s before the onset of subtle cognitive or functional changes, these biomarkers could be used as surrogate endpoints for the approval of a new drug.  Since there are no accepted biomarkers for Alzheimer’s Disease, the FDA has encouraged researchers to develop them.