The FDA sidelined U.S. biotech Cempra’s new generation antibiotic with a complete response letter last week over safety concerns, as well as because of issues it has with the Wockhardt plant making the API for it. Days before the CRL was issued, the FDA had issued a warning letter to that plant in India, citing it for contamination and data integrity concerns.
The letter, posted today, was issued Dec. 23. It stemmed from an inspection a year before at the sterile API plant in Ankleshwar, Gujarat. It was known the plant was in trouble with the FDA because the agency slapped it with an import alert in August, banning both the human and animal antibiotics made at the plant.
Those problems had already led Chapel Hill, North Carolina-based Cempra to announce in November that there could be a delay for the consideration of approval of the experimental oral and intravenous antibiotic solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults. It said it had started looking for another supplier for the API.
According to Cempra’s announcement last week, the manufacturing concerns the FDA has with the Wockhardt plant, as well as a Hospira facility making API for it, are only a small part of the FDA’s concerns with its antibiotic. The agency said it wants the company to do a much larger clinical study to assess the potential for “hepatic adverse effects.”
But the CRL also noted that investigators had noted deficiencies with Wockhardt’s and Hospira’s manufacturing facilities during recent inspections, and that those needed to be taken care of prior to approval of the antibiotics. Cempra hopes to discuss those issues at a meeting with the FDA where it also will update the agency on its efforts to have another contractor, Uquifia, approved as an alternate GMP manufacturing facility for the solithromycin API.
The warning letter cites inadequate air handling, problems that were noted with the gowns worn by personnel conducting sterile work, as well as discovering some employees has hidden, even destroyed, test results.
The warning letter for Wockhardt is the latest in a series of FDA regulatory issues the Indian drugmaker has been trying to overcome since 2013, when the agency banned products from its plants in Waluj and Chikalthana for a variety of problems that it laid out later in warning letters.