Eight Investigational Drugs Line-up for November Approvals

As we reported in our weekly update on Tuesday, the FDA approved baloxavir marboxil (Xofluza from Roche and Shionogi for the treatment of acute uncomplicated influenza in patients 12 year or older that have been symptomatic for 48 hours or less. The approval came two months ahead of its 12/24/2018 PDUFA Date. The drug had no priority designation. 

Here are the potential budget- busting investigational drugs with November PDUFA Dates - two are due by this weekend.:

Oliceridine from Trevena with a PDUFA Date of Nov 2, 2018 is an Opioid analgesic. It is delivered Intravenously Bolus for Post-op pain. An FDA advisory committee voted 8-7 not to recommend approval of oliceridine and recommended additional clinical trials. The committee also noted the potential for QT prolongation.

Sublingual sufentanil (Desuvia) from AcelRx Pharmaceuticals has a Nov 3, 2018, PDUFA Date. It’s an Opioid analgesic for Post-op and battlefield pain. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval of sublingual sufentanil tablets.

Mid-month, revefenacin from Mylan Pharmaceuticals/Theravance Biopharma has a Nov 13, 2018, PDUFA Date. This drug is a muscarinic receptor antagonist for COPD that is administered by nebulization, offering an alternative for patients unable to use a MDI. 

Secondly at mid-month, Rifamycin-SV from Salix/Cosmo Pharmaceuticals whose PDUFA Date is Nov 16, 2018. Rifamycin is a single dose oral antibacterial agent to treat Traveler's diarrhea. Rifamycin has Fast Track and Qualified Infectious Disease Product priority designations.

Finally, we have four end-of-the-month budget-busters:

Larotrectinib from Loxo Oncology/Bayer with a Nov 26, 2018, PDUFA Date.  Larotrectinib targets tumors with NTRK-fusion proteins.  Loxo estimates there are 1,500 and 5,000 late-stage cancer patients in the U.S. and a similar number in Europe with the mutation. In November 2017, Bayer bought global development rights for larotrectinib. The FDA has granted larotrectinib an accelerated review for use in treating locally advanced or metastatic tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion regardless of site. 

Amifampridine (Firdapse) from Catalyst/BioMarin Pharmaceutical, PDUFA Date of Nov 28, 2018, is a Potassium Channel Blocker in oral form to treat Lambert-Eaton Myasthenic Syndrome (LEMS) and Spinal Muscular Atrophy (SMA). There is controversy over the drug because it is a slightly tweaked version of an old drug, 3,4-DAP, from U.S. drug maker Jacobus Pharmaceutical, who is giving it away for free.  Concern is that Catalyst could charge $60,000 to $80,000 per year for providing little development or improvement. Amifampridine has Orphan Drug and Breakthrough Therapy priority designations. 

Gilteritinib from Astellas/Kotobuk with a Nov 29, 2018, PDUFA Date, is an oral Tyrosine Kinase Inhibitor targeting Acute Myeloid Leukemia and Non-small cell lung cancer. The drug has orphan drug and fast track priority designations. 
Pfizer’s lorlatinib closes the month with a Nov 30, 2018, PDUFA Date. The drug is an oral ALK/ROS1 tyrosine kinase inhibitor for Anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Loriatinib has Orphan Drug and Breakthrough Therapy priority designations.

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