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news.Onyx Pharma has stated that it will delay its new drug application (NDA) filing for Carfilzomib based on a recent meeting with the Chemistry, Manufacturing and Controls (CMC) review division of the US Food and Drug Administration (FDA).
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FDA has requested additional CMC information related to commercial-scale manufacturing of Carfilzomib.
Onyx had previously anticipated filing an NDA by the end of 2010 for accelerated approval of Carfilzomib and now expects that its NDA filing for accelerated approval could occur as early as mid-year 2011.
The Phase 3 trials are on schedule and actively enrolling patients, and this change is not expected to impact any of the Carfilzomib trials or other development plans, Onyx said.
Onyx claimed that in preparation for commercial-scale production, the company made manufacturing process enhancements in the production of Carfilzomib, which are customary when migrating from clinical to commercial-scale manufacturing.
In a recently completed manufacturing-scale run, Onyx observed minor variations that are believed to be primarily related to equipment temperature variances.
Onyx has additional data and is generating more information to share as part of the ongoing dialogue with the CMC review division in preparation for an NDA filing.
Onyx president and CEO Anthony Coles said that they were confident in the clinical and preclinical data package supporting the Carfilzomib NDA and in their manufacturing strategy.
“We believe that by providing this supportive data, we will strengthen our NDA package, thus enabling us to bring Carfilzomib to patients with multiple myeloma as quickly as possible,” Coles said.