The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.
The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August. Let’s take a look.
The FDA gave Merck & Co. a PDUFA target action date of September 23 for its supplemental Biologics License Application (sBLA) for its anti-PD-1 drug Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). This was evaluated under Priority Review. The agency approved it for this indication and combination on August 20, 2018.
The supplemental application was based on overall survival (OS) and progression-free survival (PFS) data from the Phase III KEYNOTE-189 clinical trial.
“Keytruda is rapidly becoming a foundation for the treatment of appropriate patients with metastatic non-small cell lung cancer,” said Roger M. Perlmutter, president, Merck Research Laboratories, in a statement in August. “Today’s approval for the expanded label for Keytruda based on data from the KEYNOTE-189 trial is an important milestone, and reinforces our steadfast commitment to improving survival outcomes, and providing hope, for more patients with lung cancer.”
Bridge Water, NJ-based Insmed Incorporated has a target action date of Friday, September 28 for its New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adults with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). It was granted Priority Review.
NTM is a rare and serious lung disease, which includes multiple symptoms like fever, weight loss, cough, lack of appetite, night sweats, bloody sputum, and fatigue. Though rare, its prevalence increased by about 8 percent a year from 1997 to 2007.
On August 7, the FDA’s Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of ALIS, as well as in favor of the surrogate endpoint of sputum culture conversion that was used in the Phase III CONVERT trial. However, in a separate vote, the committee voted against the safety and effectiveness of the drug in the broadest population of adults with NTM lung disease caused by MAC.
“We are very pleased by the outcome of today’s advisory committee meeting, which recognized the role ALIS may be able to play in addressing the significant unmet medical need among patients suffering from NTM lung disease caused by MAC, a chronic, debilitating and potentially fatal infection,” stated Will Lewis, Insmed’s president and chief executive officer.
Antares Pharma, based in Ewing, NJ, has a target action date of Saturday, September 29 for its investigational new drug for testosterone replacement therapy, Xyosted. The date was set in April, after the company resubmitted the drug application on March 29, 2018 after receiving a Complete Response Letter from the FDA.
The agency originally rejected the company’s NDA for Xyosted in October 2017. The CRL specified two deficiencies in the clinical data. The FDA indicated they were concerned the drug could cause a clinically problematic increase in blood pressure, as well as possible occurrence of depression and suicidality. There were no issues cited related to manufacturing or efficacy. As part of its resubmission, the company re-analyzed the data, but was not required to conduct additional clinical trials.
At the company’s second-quarter report on August 7, Robert F. Apple, company president and chief executive officer, said in a statement, “The recent launch of AMAG’s Makena auto injector product, the addition of a rescue pen development program to our business alliance pipeline and the potential for a late third quarter approval of our proprietary product Xyosted should continue to drive additional increases in revenue going forward….We are also focused on Xyosted launch planning as we continue to identify highly experienced sales representatives and stand ready to bring them on board contingent upon product approval on the September 29, 2018 target action date.”
