Technically, there are four Prescription Drug User Fee Act (PDUFA) dates on the calendar; however, one was approved a couple of months earlier, while another may be delayed because the Food and Drug Administration (FDA) has been reassessing its policies related to opioid pain medications.
Following are the drug companies that have a target action alert from the FDA:
- Polivy for Large B-Cell Lymphoma by Seattle Genetics
The FDA approved Polivy developed by Seattle Genetics on June 10, a couple of months ahead of its actual target action date of August 19. The drug was approved in combination with bendamustine and Rituxan (rituximab) for adults with refractory or relapsed diffuse large B-cell lymphoma. Polivy is an antibody-drug conjugate that is associated with a cancer-killing agent.
- Antibiotic Lefamulin by Nabriva Therapeutics
Nabriva Therapeutics has an FDA target action date of August 19 for its drug Lefamulin, which is developed in intravenous (IV) formulation as well as oral formulation. Lefamulin is a potent antibiotic for community-acquired bacterial pneumonia (CABP). The European Medicines Agency (EMA) has also approved this antibiotic for review.
- Vyondys 53 for Duchenne Syndrome by Sarepta Therapeutics
Sarepta Therapeutics has an FDA target action date of August 19 for its drug called Vyondys 53 (golodirsen), which is developed for the treatment of Duchenne Muscular Dystrophy (DMM), or Duchenne syndrome. DMD is a dangerous genetic neuromuscular disorder affecting mostly boys. The disease affects at least one in every 3,500 to 5,000 males across the world.
- NKTR-181 Opioid Pain Medications by Nektar Therapeutics
Nektar Therapeutics has an FDA target action date of August 29 for its New Drug Application (NDA) for NKTR-181, which is an opioid pain medication. Earlier this year, the FDA informed Nektar that it has been extending the review period for three months to review data from the company’s two additional preclinical studies.