FDA Action Alert: Ortho Dermatologics, Akcea Therapeutics and Merck
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
The FDA originally had a target action date of October 5 for Acorda Therapeutics’ New Drug Application for Inbrija (levodopa inhalation powder) to treat symptoms of OFF periods of Parkinson’s disease patients taking a carbidopa/levodopa regimen. However, on September 13, the company announced that the agency had extended the PDUFA date to January 5, 2019, related to recent submissions the company made after the FDA asked for more data on chemistry, manufacturing and controls (CMC). The FDA decided the submissions were a major amendment that required more time to review.
Ortho Dermatologics, a division of Valeant Pharmaceuticals (now named Bausch Health) has a PDUFA date of October 5 for its NDA for Jemdel (halobetasol propionate) lotion for plaque psoriasis with dosing for as long as eight weeks. In February, Bausch Health chairman and chief executive officer, Joseph C. Papa, stated, “The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition. If approved, we believe Jemdel will be an important option for patients with plaque psoriasis.”
Verastem had an October 5 target action date for its NDA for full approval of duvelisib for patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). However, on September 24, the FDA approved Copiktra for those indications.
“With Today’s FDA approval of Copiktra, Verastem oncology is delivering upon our commitment to patients with cancer by bringing a new oral medicine to market,” stated Robert Forrester, president and chief executive officer of Verastem Oncology. “We are pleased to be able to introduce Copiktra during National Blood Cancer Awareness Month. At Verastem Oncology, we are driven by the strength and courage of those battling cancer, and we are committed to advancing therapies such as Copiktra with the potential to make a significant impact for patients, their caregivers and physicians.”
Akcea Therapeutics has a PDUFA target date of October 6 for Tegsedi (inotersen) for stage 1 or stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis (hATTR). The drug was approved for those indications in Europe in July. The drug was approved by the European Commission (EC) based on results from the Phase III NEURO-TTR trial.
“With the EC’s decision, Tegsedi is now the world’s first and only RNA-targeted therapeutic approved for patients with hATTR amyloidosis,” stated Paula Soteropoulos, Akcea’s chief executive officer. “With subcutaneous delivery, Tegsedi puts treatment in the patients’ hands while bringing the significant benefits shown in the NEURO-TTR study in both measures of neuropathy and quality of life for people living with this serious and fatal disease.”
Merck has a PDUFA date of October 6 for a supplemental Biologics License Application (sBLA) for Gardasil, the company’s 9-valent Human Papillomavirus (HPV) vaccine. The request is to expand the age indication for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases associated with the nine HPV types covered by the vaccine.
Alain Luxembourg, director of Merck’s clinical research, told HemOnc Today, “Exposure to HPV does not stop at age 26 years. We now have a significant amount of epidemiological and real-world data that show adults older than age 26 years are exposed to HPV and are susceptible to infection. We have a population that is at risk and is not protected.”