FDA Decisions in July
by Kinjel Shah
We are into the second half of the year. It’s time to analyze how the first half turned out to be for pharma and biotech stocks in terms of FDA decisions. The regulatory body approved 17 novel drugs in the first half of 2018, which is less than the year-ago period figure of 23. However, with several FDA decision lined up for the second half, a higher number of drugs could be approved in the rest of the year.
Key FDA approvals in the first half included Amgen/Novartis’s first CGRP antibody Aimovig/erenumab for prevention of migraine, Johnson & Johnson’s next-generation oral androgen receptor (“AR”) inhibitor Erleada (apalutamide) for pre-metastatic prostate cancer (CRPC), Vertex Pharmaceuticals’ third medicine to treat the underlying cause of CF, Symdeko, which is a combination of tezacaftor and ivacaftor and BioMarin Pharmaceuticals’ Palynziq to treat phenylketonuria (PKU).
With the drug development process being lengthy and time-consuming, plus requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts.
Let’s take a look at a few important regulatory events scheduled for the month of July.
Drug and Biotech Stocks Awaiting FDA Decisions in July: Indivior (INVVY)
FDA Decision on Indivior’s Schizophrenia Injection RBP-7000: On Jul 28, the FDA is expected to give its decision on Indivior‘s RBP-7000, which has been developed for the treatment of schizophrenia.
RBP-7000 is a once-monthly injectable risperidone given using the Atrigel delivery system. Indivior is a Zacks Rank #3 (Hold) stock.
Drug and Biotech Stocks Awaiting FDA Decisions in July: Progenics (PGNX)
Progenics Pharmaceuticals’ Azedra Review: Progenics new drug application (NDA), looking to get its pipeline candidate, Azedra approved for the treatment of patients suffering from malignant rare neuroendocrine tumors — pheochromocytoma and paraganglioma — is under review.
The FDA is expected to give its decision on Jul 30, after a three-month delay from the previous FDA action date in March. Azedra was added to Progenics’ portfolio with the acquisition of Molecular Insight Pharmaceuticals in 2013.
Drug and Biotech Stocks Awaiting FDA Decisions in July: Insys Therapeutics (INSY)
Decision on Insys Therapeutics’ Pain Candidate: On Jul 28, the FDA is also expected to give its decision on Insys Therapeutics’ buprenorphine sublingual spray for moderate-to-severe acute pain. It is important to remember that in May an FDA advisory committee voted against its approval.
The company had filed a new drug application (“NDA”) in September last year based on positive data from a pivotal study on the candidate. The FDA accepted the NDA for review in December assigning a PDUFA date of Jul 28, 2018.
It is quite possible that the unfavorable vote by the committee may influence the FDA’s decision and delay the approval of the drug.
Drug and Biotech Stocks Awaiting FDA Decisions in July: GlaxoSmithKline (GSK)
Will an FDA Panel Back New Indication for Glaxo’s Nucala?: Toward the end of the month, an FDA panel is expected to give its opinion on GlaxoSmithKline‘s label expansion filing for eosinophilic asthma drug, Nucala (mepolizumab) for a new indication – chronic obstructive pulmonary disease (COPD). With the latest filing, Glaxo is looking to get Nucala approved as an add-on maintenance treatment of COPD with an eosinophilic phenotype.
Nucala is presently approved for treating severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (“EGPA”). Glaxo hadfiled a supplemental Biologics License Application (sBLA) to the FDAfor label expansion of Nucala to include use in COPD in November last year.
Although the FDA takes the recommendations of its panels/advisory committee into account while reviewing applications, it is not bound to follow the same.