Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
Agency Granted Accelerated Approval to Astellas Pharma’s Padcev
The FDA approved Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) for urothelial cancers, specifically adults with locally advanced or metastatic urothelial cancer who have previously received a checkpoint inhibitor and platinum-containing chemotherapy. Padcev is a Nectin-4-directed antibody and microtubule inhibitor conjugate, a new type of cancer treatment.
“Antibody-drug conjugates are strategic tools in the targeted treatment of cancer,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research (CDER). “These conjugates combine the ability of monoclonal antibodies to target specific receptors on cancer cells and then deliver a drug to the cancer cell.”
FDA Works to Increase Oversight of Compounding Drug Facilities
Compounding is typically where a licensed pharmacist, physician or outsourcing facility mixes, combines or changes ingredients of a drug to create a tailored medication for an individual patient. The FDA oversight isn’t as stringent as it is for standard drugs and the agency is working to make sure it continues to have access to these facilities for inspections and oversight. To do so, they announced the Compounding Quality Center of Excellence, which is engineered to improve collaboration and provide educational programs for compounding outsourcing facilities with the goal of improving the overall quality of compounded medicines.
“By providing comprehensive, accessible learning tools, we will support outsourcing facilities in reliably producing high-quality compound products that meet FDA’s standards,” said Janet Woodcock, director of the FDA’s CDER.
Framing Opioid Prescribing Guidelines for Acute Pain
In August 2018, the agency hired the National Academies of Sciences, Engineering, and Medicine (NASEM) to develop evidence-based guidelines for opioid prescribing for acute pain. NASEM published the consensus report yesterday. The FDA will take into consideration the report’s recommendation as it implements its Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) provision requiring the opioid analgesic prescribing guidelines.
“The FDA remains committed to addressing this national crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal importation and sale of opioid products,” the agency stated.
Agency Approved Merck’s Ebola Vaccine, Ervebo
On December 19, the FDA approved Merck’s Ervebo, the first FDA-approved vaccine for Ebola, caused by Zaire ebolavirus. This came about a month after the European Commission approved it.
Ervebo is being used under a “compassionate use” program in the eastern Democratic Republic of Congo (DRC), which has been under the second-largest Ebola outbreak on record. Since August 2018, more than 3,000 people in the country tested positive for Ebola and more than 2,000 people died of it. In the last year, more than 250,000 people have been dosed with Ervebo.
“While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs. “Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization.”
