When the FDA last month rejected Outlook Therapeutics’ application for a reformulated version of Roche’s cancer drug Avastin, the agency pointed to issues with the drug’s manufacturing process in a complete response letter (CRL).
Now, the specific problems have become more clear as Fierce Pharma has obtained the Form 483 filing (PDF) for a site associated with the drug’s production.
Ajinomoto Bio-Pharma Services was one of the two manufacturers Outlook tapped for the drug, which is called Lytenava. After a preapproval inspection in January, the company’s site in San Diego was flagged for quality oversight and control issues plus equipment maintenance problems, according to the Form 483.
The agency deemed the plant’s quality overnight of validation activities inadequate. Specifically, one machine was validated using only one batch run as opposed to three, according to the FDA.
In addition, the facility and equipment maintenance weren’t up to par, the FDA said. The agency said the company skirted protocols for cleaning and sanitation as well as quality control procedures.
Late last month, the FDA turned down Outlook’s approval bid for the first ophthalmic formulation of Roche’s Avastin. While Avastin has been approved for many years to treat a variety of cancers, the med has long been used off-label to treat eye diseases.
Outlook’s ophthalmic reformulation is meant to prevent doctors from having to use unapproved and repackaged Avastin. The company was seeking approval to treat wet age-related macular degeneration (AMD).
After the rejection, Outlook’s CEO Russell Trenary called the manufacturing and control issues “addressable” and “manageable” during a call with analysts.
In a statement at the time, he said the company would request a formal meeting with the FDA “as soon as possible” to determine next steps
