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

Shanthi Rexaline

FDA activity remained brisk in August. The FDA gave its nod for a majority of drugs that came up for review, although Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)'s jet lag disorder drug Hetlioz and Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Duchenne muscular dystrophy drug golodirsen failed to clear the FDA hurdle.

Seven new molecular entities, or NMEs, were approved in August, taking the total number of NME approvals thus far this year to 25 compared to 35 by the same period last year.

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 are the key PDUFA action dates to watch for in September.

Roche Seeks Lung Cancer Nod For Tecentriq-Chemo Combination

  • Company: Roche Holdings AG Basel ADR (OTC: RHHBY) and Celgene Corporation (NASDAQ: CELG)
  • Type of Application: sBLA
  • Candidate: Tecentriq along with chemotherapy - carboplatin and Abraxane
  • Indication: first-line treatment of metastatic non-squamous non-small cell lung cancer in patients, who do not have EGFR or ALK genomic tumor aberrations
  • Date: Sept. 2

The BLA, which was supported by the results from the Phase 3 Impower130 study, was accepted for review Jan. 17. The results of the study showed that it met its co-primary endpoints of overall survival and progression-free survival.

In December 2018, Tecentriq was approved in combination with Avastin, paclitaxel and carboplatin for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

Can Second Time Be Charm For Xeris?

  • Company: Xeris Pharmaceuticals Inc (NASDAQ: XERS)
  • Type of Application: NDA
  • Candidate: Gvoke
  • Indication: severe hypoglycemia
  • Date: Sept. 10

Xeris announced June 6 the FDA gas extended the initial PDUFA action date for Gvoke – ready-to-use glucagon injection - by three months. The FDA reasoned that the recent submission by Xeris in response to an information request from the FDA constituted to a major amendment to the NDA. Therefore, the agency deemed it fit that the review period is extended by three months to allow for a full review of the submission.

Gvoke, which leverages XeriSol, one of the company's two proprietary formulation tech platforms, if approved, could be the first ready-to-use, room-temperature stable liquid glucagon for use by people with diabetes and other indications to prevent or manage various forms of hypoglycaemia.

Ardelyx Hopes For Smooth Passage For Constipation Drug

  • Company: Ardelyx Inc (NASDAQ: ARDX)
  • Type of Application: NDA
  • Candidate: Tenapanor
  • Indication: irritable bowel syndrome with constipation
  • Date: Sept. 12

Tenapanor is a minimally-systemic small molecule that acts locally in the gastrointestinal tract to inhibit the sodium transporter NHE3 and reduce sodium absorption in the GI tract, thus increasing intestinal fluid.

The NDA was accepted Nov. 13, 2018, with a standard review designation.

Merck's HIV Cocktail Awaits FDA Clearance

  • Company: Merck & Co., Inc. (NYSE: MRK)
  • Type of Application: sNDA
  • Candidate: Pifeltro and Delstrigo
  • Indication: treatment of HIV-1 infection in adult patients not previously treated with antiretroviral therapy
  • Date: Sept. 20

The FDA accepted for review Merck's sNDA for Pifeltro (doravirine, 100mg) and Delstrigo (doravirine100mg, lamivudine,3TC, 300 mg, and tenofovir disoproxil fumarate, 300 mg) on Jan. 22. The combo treatment is being evaluated in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed.

Will Tidings Be Sweet For Novo Nordisk's Type 2 Diabetes Drug?

  • Company: Novo Nordisk A/S (NYSE: NVO)
  • Type of Application: NDA
  • Candidate: Semaglutide
  • Indication: an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes
  • Date: Sept. 20 (estimated)

Novo Nordisk submitted the NDA March 20 for Semaglutide, the first once-daily glucagon-like peptide-1 receptor agonist in a pill form. Assuming a six-month priority review, the decision is likely to come through by late September.

J&J-Genmab Await FDA Nod For Multiple Myeloma Drug Combo

  • Company: Johnson & Johnson (NYSE: JNJ) and GENMAB A/S/S ADR (NASDAQ: GMAB)
  • Type of Application: sBLA
  • Candidate: Daratumumab in combination with bortezomib, thalidomide and dexamethasone, or VTd
  • Indication: multiple myeloma
  • Date: Sept. 26

Genmab has licensed daratumumab to J&J's Janssen unit under a 2012 agreement. The FDA accepted the sBLA for daratumumab in combination with VTd on May 30 following the regulatory submission done in April. The combination is being evaluated as a treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant.

J&J Seeks Label Expansion For Invokana

  • Company: Johnson & Johnson
  • Type of Application: sNDA
  • Candidate: Invokana
  • Indication: for treating chronic kidney disease in Type 2 diabetes patients
  • Date: Sept. 27

Invokana was assessed in a study dubbed CREDENCE, which evaluated the efficacy and safety of Invokana versus placebo in high-risk patient population when used in addition to standard of care.

Adcom Meeting Schedule

FDA's Allergenic Products Advisory Committee is scheduled to meet Sept. 13 to discuss and make recommendations on the safety and efficacy of Aimmune Therapeutics Inc (NASDAQ: AIMT)'s Allergen Powder indicated for reducing the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.

The Non-prescription Drugs Advisory Committee of the FDA is set to discuss GlaxoSmithKline plc (NYSE: GSK)'s NDA for over-the-counter marketing of nicotine oral spray. This is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking

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