November Regulatory Outlook

RedHill Biopharma’s combination of amoxicillin, omeprazole, rifabutin (Brand Name: Talcia) for the eradication of H. pylori has a PDUFA Date of November 2, 2019. A Phase III trial demonstrated the combination of amoxicillin, omeprazole and rifabutin delivered an 84% eradication of H. pylori compared to 58% eradication with amoxicillin and omeprazole in dyspepsia patients with confirmed H. pylori infection. Of the thirty-six investigational drugs in the Pharmaceutical Pipeline Tracker, Talcia is the only drug targeting the eradication of H. pylori. It has FDA Priority Designations as a Fast Tracked Qualified Infectious Disease Product.

Short list for November. So, let’s take a quick look at the seven investigational drugs with December PDUFA Dates.  

Celgene/Acceleron’s luspatercept – PDUFA Date: Dec 4, 2019, a TGF-beta signaling modulator via subcutaneous injection targeting Beta thalassemia, Myelodysplastic Syndromes.

Enzyvant’s RVT-802 – PDUFA Date: Dec 6, 2019, a tissue-based regenerative therapy via transplantation targeting pediatric congenital athymia. RVT-802 has four FDA Priority Designations: Fast Track, Breakthrough Therapy, Rare Pediatric Disease, and Regenerative Medicine Advance Therapy.

Intra-Cellular Therapies’ lumateperone - PDUFA Date: Dec 27, 2019, an oral atypical antipsychotic to treat acute and residual schizophrenia. Lumateperon has an FDA Fast Track Priority Designation.

Allergan’s ubrogepant – PDUFA Date: Dec 27, 2019, is an oral gepant to treat acute migraines.

Eisai/Purdue’s lemborexant – PDUFA Date: Dec 27, 2019 is an oral orexin receptor antagonist targeting Insomnia.

ViiV Healthcare/Janssen’s cabotegravir/rilpivirine – PDUFA Date: Dec 29, 2019, is an INSTI/NNRT delivered either orally or via Intramuscular injection as an HIV treatment.

AMCP Nexus 2019 on Alzheimer’s
Our October 24, 2019 post, Update on Investigational Drugs for Alzheimer ’s Disease, noted that progress was anticipated in the treatment of the disease this year. But the newswires have become largely radio silent. However, a comprehensive presentation on the diagnosis, treatment, and prevention of Alzheimer’s disease was recently given at AMCP Nexus 2019, according to a report filed by Jack Carafano from Day 1 of the conference. Here’s a link to Jack’s report.