Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

In a final push before the closing of the year, the FDA deemed it fit to clear even long pending ones, including Flexion Therapeutics Inc's FLXN sNDA for the updation of the label for its osteoarthritis drug Zilretaa.

About seven new molecular entities, or NMEs, were approved in the month, including Allergan plc's AGN migraine treatment Ubrelvy and Sarepta Therapeutics Inc's SRPT Duchenne muscular dystrophy drug Vyondys 53.

A NME is a drug that contains an active ingredient, which hasn't been approved by the FDA previously, either as a single ingredient drug or as part of a combination product. The number of NME approvals is considered a measure of innovation among biotechs.

NME approvals for the year totaled 48, a sizable number, although paling in significance before 2018's 59.

There was rejection too, with the FDA turning down Correvio Pharma Corp's CORV atrial fibrillation drug Brinavess.

Related Link: 10 Biotech M&A Targets Under The Scanner For 2020

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Here're the key PDUFA dates for the first month of the new year.

Epizyme Awaits FDA Verdict On Cancer Drug After Positive Adcom Vote

• Company: Epizyme Inc EPZM
• Type of Application: NDA
• Candidate: tazemetostat
• Indication: metastatic or locally advanced, unresectable epithelioid sarcoma
• Date: Jan. 23

The NDA was accepted for accelerated review July 25, and ahead of the decision, the application was reviewed by FDA's Oncologic Drugs Advisory Committee Dec. 18. Despite expectations for a negative verdict, the panel unanimously recommended approval of the drug.

Go Or No Go For Merck's Antibacterial Drug

• Company: Merck & Co., Inc. MRK
• Type of Application: NDA & sNDA
• Candidate: DIFICID (fidaxomicin)
• Indication: Clostridium difficile infections
• Date: Jan. 24

Merck said Oct. 2 the FDA accepted an NDA for oral suspension formulation and a sNDA for tablets and oral suspension for the treatment of Clostridium difficile infections in children aged six months or older.

Difficid is a macrolide antibiotic medicine indicated to treat Clostridium difficile-associated diarrhea in adults, ages 18 years or older.

Can Aimmune Peanut Allergy Drug Win FDA Nod?

• Company: Aimmune Therapeutics Inc AIMT
• Type of Application: NDA
• Candidate: Palforzia (AR101)
• Indication: peanut allergy
• Date: late January

FDA's Allergenic Products Advisory Committee voted 7-to-2 in favor of the efficacy of Palforzia and 8-to-1 in favor of its safety. Palforzia is a biologic oral immunotherapy being evaluated to treat peanut allergy in patients, aged 4 through 17 years.

In an interview with Benzinga following the Adcom verdict, CFO Eric Bjerkholt said the company is gearing for a commercial launch in about one to two weeks following the approval, and gave a tentative timeframe of late January or early February.

Adcom Meetings

A joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Jan. 14, Nektar Therapeutics's NKTR NDA for oxycodegol, a NME full mu-opioid receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment.

The same committees will discuss Jan. 15, IntelliPharmaCeutics International Inc.'s IPCIF NDA for an extended-release oral tablet formulation of oxycodone. The investigational candidate is being evaluated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

The Anesthetic and Analgesic Drug Products Advisory Committee will review Jan. 16, DURECT Corporation's DRRX NDA for bupivacaine extended-release solution for instillation, for the proposed indication of post-surgical analgesia.