FDA Watchlist: Catalysts To Look Out For This February

Priority Review for Gilead's HIV Treatment: Gilead Sciences GILD is also awaiting a decision from the FDA this month for its new drug application ("NDA") for an investigational, fixed-dose combination of bictegravir (50 mg) ("BIC"), an integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. The NDA is under priority review with a decision expected on February 12. With the company's hepatitis C virus ("HCV") franchise seeing declining sales, Gilead is focusing on its HIV franchise for growth. The company's HIV portfolio includes drugs like Genvoya, Truvada, Atripla, Descovy, Odefsey, Complera and Stribild which contributed approximately $9.5 billion to total sales in the first nine months of 2017. Gilead's TAF-based products like Genvoya, Descovy and Odefsey remain key growth drivers.

Valeant Pharmaceuticals International, Inc. VRX also expects to hear from the FDA about the approval status of Plenvu, a bowel cleanser used in preparation for colonoscopies (FDA action date: February 13). Moreover, companies like KemPharm and Apricus expect a response from the FDA this month for their resubmitted NDAs. While KemPharm has a PDUFA date of February 23 for Apadaz (an immediate-release, abuse-deterrent hydrocodone/acetaminophen combination product candidate), Apricus will get to know the approval status of its resubmitted Vitaros (topically delivered treatment for erectile dysfunction) NDA on February 17.

Meanwhile, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee will be meeting on February 14 to discuss Pacira Pharmaceuticals's PCRX supplemental new drug application (sNDA) for Exparel (bupivacaine liposomal injectable suspension), to produce local analgesia and as a nerve block to produce regional analgesia.

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