FDA Action Alert: It's a Big Week


It’s a big week for the U.S. Food and Drug Administration (FDA) with plenty of upcoming decisions.

Achaogen’s plazomicin, an antibiotic for multi-drug resistant (MDR) gram-negative infections has a PDUFA date of Monday, June 25. The agency accepted the NDA for review on January 2, and granted it Priority Review. The drug is up for approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. On May 2, the FDA’sAntimicrobial Drugs Advisory Committee voted unanimously in favor of the drug for cUTI, 15 to zero. However, in a vote of whether the company had provided substantial evidence of safety and effectiveness for the treatment of bloodstream infections, four voted yes and 11 voted no.

GW Pharmaceuticals has a PDUFA date of June 27 for its cannabinoid product, Epidiolex (cannabidiol or CBD) for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, both rare and difficult to treat conditions of childhood-onset epilepsy. The drug was granted Priority Review status. The drug is also being reviewed by the European Medicines Agency (EMA) and is expected to have a decision there in the first quarter of 2019. An FDA Advisory Committee gave a positive review earlier this year.

The FDA had a decision date for Merck’s supplemental Biologics License Application (sBLA) for Keytruda (Pembrolizumab) for treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy of June 28. It was the first filing and Priority Review granted for the anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for Keytruda. But the agency got to it on June 12, approving it for the indication. “Keytruda is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a statement.

AlkermesNDA for Aripiprazole Lauroxil NanoCrystal Dispersion for treatment of schizophrenia has a PDUFA date of Saturday, June 30. The drug in conjunction with a single oral dose of 30 mg aripiprazole would replace the need for three weeks of concomitant oral aripiprazole with the first dose of Aristada, Aklermes’ drug for schizophrenia.

Also on Saturday, June 30, the FDA has a PDUFA date for Array BioPharmas binimetinib and encorafenib combination for BRAF-mutant advanced, unresectable or metastatic melanoma. It is also being reviewed by the EMA, the Swiss Medicines Agency (Swissmedic), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). At the company’s third-quarter financial report on May 9, the company’s chief executive officer, Ron Squarer, said in a statement, “Preparations for the anticipated U.S. launch of encorafenib and binimetinib in BRAF-mutant melanoma are well underway. We are pleased to have our entire commercial leadership and infrastructure in place and are poised for an exciting 2018, as we look ahead to commercialization and additional data updates from our encorafenib and binimetinib clinical trials.”

Demira’s glycopyrronium tosylate, formerly DRM04, for adults and adolescents with primary axillary hyperhidrosis (excessive underarm sweating), a medical condition beyond what is normal for temperature regulation, is also up for a decision on June 30. If approved, it will be the first FDA-approved topical wipe medication specifically for primary axillary hyperhidrosis.

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