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

The FDA approval machinery worked overtime in May, with several new labelings, original approvals and new molecule approvals coming through in the month.

The month saw the approval of two new molecular entities, or NMEs: Novartis AG NVS's Piqray in combination with fulvestrant to treat postmenopausal women and men, with hormone HR-positive HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer and Pfizer Inc. PFE's Vyndaqel and Vyndamax capsules for treating heart disease caused by transthyretin-mediated amyloidosis.

Novartis also won approval for Zolgensma, its novel gene therapy for spinal muscular atrophy Type 1.

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 dates to watch for June.

Merck Seeks Approval For Expanded Indication For Antibiotic

• Company: Merck & Co., Inc. MRK
• Type of Application: sNDA
• Candidate: Zerbaxa (ceftolozone and tazobactam)
• Indication: Treating adult patients with ventilated nosocomial (hospital-acquired) pneumonia
• Date: June 3

Zerbaxa is indicated for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain susceptible gram-negative microorganisms, and also for the treatment of adult patients with complicated intra-abdominal infections in combination with metronidazole.

In April, Merck released the results of a Phase 3 trial, showing non-inferiority of Zarbaxa to meropenem, the active comparator, in the primary and key secondary endpoints.

Xeris' Glucagon Autoinjector For Low Blood Sugar

• Company: Xeris Pharmaceuticals Inc XERS
• Type of Application: NDA
• Candidate: Gvoke HypoPen
• Indication: Treating severe hypoglycemia in people with diabetes
• Date: June 10

Gvoke HypoPen is Xeris' lead product candidate – a ready-to-use, room-temperature stable liquid glucagon rescue pen auto injector. Glucagon is the standard-of-care for treating severe hypoglycemia.

"Compared to the current glucagon rescue option for people with diabetes who are at risk for severe hypoglycemia, the Xeris glucagon rescue pen would eliminate the need for reconstitution and dramatically simplify the preparation and administration process," according to Xeris.

Can Merck Snatch Another Approval For Keytruda?

• Company: Merck
• Type of Application: sBLA
• Candidate: Keytruda
• Indication: First-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma, or HNSCC
• Date: June 10

The FDA accorded priority review status for the application, and Keytruda is being evaluated as a monotherapy, or in combination with platinum and 5-fluorouracil chemotherapy. The application is supported by the pivotal Phase 3 KEYNOTE-048 trial, in which Keytruda demonstrated a significant improvement in overall survival compared with the standard-of-care.

Merck's Keytruda For Lung Cancer

• Company: Merck
• Type of Application: sBLA
• Candidate: Keytruda
• Indication: For treating patients with advanced small cell lung cancer, or SCLC, whose disease has progressed after two or more lines of prior therapy
• Date: June 17

The regulatory submission was based on data from the SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials.

Palatin's Drug For Hypoactive Sexual Desire Disorder Awaits

• Company: AMAG Pharmaceuticals, Inc. AMAG and Palatin Technologies, Inc. PTN
• Type of Application: NDA
• Candidate: Vyleesi (bremelanotide)
• Indication: Treating premenopasal women with hypoactive sexual desire disorder, or HSDD
• Date: June 23

Vyleesi is a novel melanocortin 4 receptor agonist under evaluation for restoring a natural sexual desire in premenopausal women with HSDD. It's administered as a subcutaneous injection under the skin using a single-use autoinjector pen. The drug developed by Palatin is being licensed to Amag.

The original PDUFA date of March 23 was pushed forward by three months to allow the regulatory agency to parse through additional Phase 1 data submitted by the company at FDA's request.

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Acer Seeks Approval For Drug To Treat Rare Genetic Disease of Connective Tissue

• Company: Acer Therapeutics Inc ACER
• Type of Application: NDA
• Candidate: Edsivo
• Indication: Treatment of vascular Ehlers-Danlos syndrome, or vEDS, in patients with a confirmed type III collagen (COL3A1) mutation
• Date: June 25

Ehlers-Danlos Syndrome is a group of hereditary disorders of connective tissues, with vEDS being the most severe subtype, where patients suffer from life-threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. The drug has received Orphan Drug Designation in 2015 and the NDA has been granted priority review as well.

Can Dupixent Get The Nod For Expanded Indication?

• Company: Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN
• Type of Application: sBLA
• Candidate: Dupixent
• Indication: Add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps, or CRSwNP
• Date: June 26

Dupixent has already been approved for eczema and as a maintenance therapy in combination with other medicines for asthma.

"Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages," the company said.

Can Alexion's Soliris Pass The Muster For NMOSD?

• Company: Alexion Pharmaceuticals, Inc. ALXN
• Type of Application: sBLA
• Candidate: Soliris (eclizumab)
• Indication: for treating patients with neuromyelitis optica spectrum disorder, or NMOSD
• Date: June 28

The sNDA was supported by comprehensive data from the PREVENT study in patients with anti-AQP4 auto antibody-positive NMOSD, who represent three-quarters of all patients with NMOSD.

NMOSD is a rare, complement-mediated disorder of the central nervous system characterized by relapses. Each relapse results in stepwise accumulation of disability, including blindness and paralysis, and sometimes premature death. There is currently no FDA-approved therapy for the indication.

Retrophin Awaits FDA Nod For New Formulation Of Rare Kidney Disorder Drug

• Company: Retrophin Inc RTRX
• Type of Application: NDA
• Candidate: new formulation of Thiola (tiopronin)
• Indication: Treatment of cystinuria
• Date: June 30

Dova's Bleeding Disorder Drug On Course For Snagging Another Approval

• Company: Dova Pharmaceuticals Inc DOVA
• Type of Application: sNDA
• Candidate: Doptelet (avatrombopag)
• Indication: Treatment for patients with chronic immune thrombocytopenia, or ITP, who have had an inadequate response to prior treatment
• Date: June 30

Allergan Seeks Label Expansion For Botox

• Company: Allergan plc AGN
• Type of Application: sNDA
• Candidate: Botox
• Indication: Treatment of pediatric patients (two years of age and older) with upper and lower limb spasticity
• Date: Second quarter (exact date not given)