The FDA has reinspected a Celltrion plant in South Korea after issuing it a warning letter earlier in the year. Although the July visit resulted in another FDA Form 483, Teva officials are confident the findings will not delay the expected approval next month of its highly anticipated migraine drug.
The reinspection for Celltrion also served as a pre-approval inspection for Teva’s fremanezumab, which has a Sept. 16 Prescription Drug User Fee Act (PDUFA) date. The plant is producing the API for the drug candidate and the warning letter knocked it off its approval track earlier this year.
“Teva is pleased that the U.S. FDA has completed its reinspection of Celltrion’s facility, as well as the Pre-Approval Inspection (PAI) for fremanezumab. We remain on track for the PDUFA action date of Sept. 16, 2018,” the Israel-based drugmaker said in an emailed statement Tuesday after the document was posted by the FDA.
“The FDA noted several observations, which is not unusual following a reinspection. Teva has reviewed the observations and do not feel they will impact our approaching PDUFA date.”
The “several observations” actually tallied eight. They ranged from failing to have written procedures for vial breakage to poorly trained employees. There was nothing around microbial contamination or inadequate investigations into batch failures, issues noted in the January warning letter.
In an emailed statement, Celltrion said the citation contained eight "manageable and correctable inspection observations" and that it expects outstanding observations to be lifted soon.
Analysts at Credit Suisse, in a note to investors, called it “a minor comment” that implied another warning letter is unlikely. That is great news for Teva, which is now counting on launching the drug this year, a development that seemed uncertain when the warning letter was first issued. The drug figures prominently in the drugmaker’s efforts to return to growth after several years of poor financial showings and drastic cutbacks.
Leerink analysts were less positive about Teva's chance of getting fremanezumab approved next month. After having an expert review the Form 483, they told clients that its specialist does not see Celltrion as having yet made adequate progress to resolve the outstanding Warning Letter and that the FDA is unlikely to approve a new drug coming out of a facility with a pending warning letter.
The delays have allowed Amgen and Novartis to get their own migraine treatment, Aimovig, to the market first. Teva officials have said getting fremanezumab approved this year will allow it to compete against Aimovig and a new drug expected from Eli Lilly.
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Celltrion at the time the issues were first uncovered pledged to turn around the situation at the plant in quick order. Teva’s drug had been set for a May PDUFA but the FDA put that off to September, a delay that appeared designed to give Celltrion a chance to make good on its pledge.
Regaining FDA confidence in its manufacturing it also important to the South Korean company winning approval of biosimilars of Herceptin and Rituxan for which it received complete response letters last year based on the plant deficiencies. The company has said it expects approval of both yet this year. That would be another positive development for Teva, which has an agreement with Celltrion to sell those products in the U.S. and Canada.