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

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August was a pretty steady month for biotechs. In terms of new molecular entity or NME approvals, the month was productive, with the FDA giving the go-ahead for seven of these products containing active moieties that haven't been previously approved by the agency.

Several drug approvals came through this month and the second-quarter reporting season panned out to be a better one for biotechs, with large-caps reporting both earnings and revenue beats.

Now, here are the PDUFA catalysts that could trigger moves in the biotech space in September.

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 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Roche Seeks Expanded Use For its Lung Cancer Drug

  • Company: Roche Holdings AG Basel ADR (OTC: RHHBY)

  • Type of Application: sBLA

  • Candidate: Tecentriq in combination with Avastin, paclitaxel and carboplatin, or chemotherapy

  • Indication: first-line treatment of non-squamous non-small cell lung cancer, or NSCLC

  • Date: Sept. 5

The application was submitted based on the Phase 3 IMpower150 study, which met the its co-primary endpoints of overall survival and progression-free survival. Tecentriq is currently approved to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK and EGFR mutations.

Will FDA Go Against Panel Verdict And Back GlaxoSmithKline's COPD Drug?

  • Company: GlaxoSmithKline plc (ADR) (NYSE: GSK)

  • Type of Application: sBLA

  • Candidate: Mepolizumab

  • Indication: Chronic obstructive pulmonary disease, or COPD, with an eosinophilic phenotype

  • Date: Sept. 7

Mepolizumab is GlaxoSmithKline's add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD, guided by blood eosinophil counts.

FDA's Pulmonary Allergy Drugs Advisory Committee, which met in late July to discuss the sBLA for the drug, voted against its approval by a 16-3 margin.

Mepolizumab has already been approved by the FDA for treating patients with severe eosinophilic asthma.

See Also: Sympathy Move: Portola Upgraded After Competitor Reports Sour Data

No Headaches For Teva's Migraine Drug?

  • Company: Teva Pharmaceutical Industries Ltd (ADR) (NYSE: TEVA)

  • Type of Application: BLA

  • Candidate: Fremanezumab

  • Indication: Migraine

  • Date: Sept. 16

The original PDUFA date for Fremanezumab was extended in May by three months. At that time, the company said there was no additional data request from the FDA.

Fremanezumab is a quarterly or monthly injection for the preventive treatment of migraine in adults.

Adamis Seeks Approval For Expanded Use Of Allergy Drug

  • Company: Adamis Pharmaceuticals Corp (NASDAQ: ADMP)

  • Type of Application: sNDA

  • Candidate: Low dose Symjepi (epinephrine) injection

  • Indication: Anaphylaxis

  • Date: Sept. 27

Adamis communicated FDA acceptance of its application Feb. 12, 2018.

Symjepi 0.3 mg dosage is already approved for treating Type 1 allergic reactions, including anaphylaxis, in patients weighing 66 pounds or greater. The low dose version, the review of which is pending before the FDA, is of 0.15 mg in strength and is intended to potentially treat patients weighing 33-65 pounds.

Anaphylaxis is a serious life-threatening allergic reaction.

Insmed Awaits Word On Lung Disease Drug After Mixed Panel Vote

  • Company: Insmed Incorporated (NASDAQ: INSM)

  • Type of Application: NDA

  • Candidate: Amikacin Liposome Inhalation Suspension, or ALIS

  • Indication: Nontuberculous mycobacterial, or NTM, lung disease caused by Mycobacterium avium complex, or MAC

  • Date: Sept. 28

NTM lung disease is a rare, progressive and potentially fatal disease. FDA's Antimicrobial Drugs Advisory Committee, which met on Aug. 7 to discuss the safety and efficacy of ALIS, voted 12 to 2 in favor of the therapy.

The committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 COVERT study reasonably predicting clinical benefit.

However, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.

Can Second Time Be Charm For Antares?

  • Company: Antares Pharma Inc (NASDAQ: ATRS)

  • Type of Application: NDA

  • Candidate: XYOSTED (testosterone enanthate)

  • Indication: Testosterone deficiency

  • Date: Sept. 29

Following the issue of a complete response letter in October 2017, Antares made a resubmission, which was deemed by the FDA as a complete, class 2 response on March 29, 2018.

Eli Lily Seeks Approval For Migraine Drug

  • Company: Eli Lilly And Co (NYSE: LLY)

  • Type of Application: BLA

  • Candidate: Galcanezumab

  • Indication: Migraine in adults

  • Date: September (no date provided)

Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide, CGRP, produced in the neurons that plays a key role in the transmission of pain. The candidate is being evaluated as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.

The BLA submission was based on three studies, namely EVOLVE-1, EVOLVE-2 and REGAIN.

Pfizer's Lung Cancer Drug Awaits FDA Nod

  • Company: Pfizer Inc. (NYSE: PFE)

  • Type of Application: NDA

  • Candidate: Dacomitinib

  • Indication: Non-small cell lung cancer, or NSCLC

  • Date: Sep. (no date provided)

The FDA accepted the NDA for Dacomitinib in April, with the candidate, a pan-human epidermal growth factor receptor tyrosine kinase inhibitor, being evaluated as a first-line treatment for patients with locally advanced o metastatic NSCLC.

Pfizer also said the European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication.

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