FDA questions delay long-acting Byetta
pharmafile | March 17, 2010 | News story | Manufacturing and Production |Â Â Bydureon, Byetta, Syncria, VictozaÂ
A once-weekly formulation of Eli Lilly and Amylin Pharmaceuticals’ blockbuster diabetes medication Byetta has hit a manufacturing hurdle en route to the registration in the US.
The FDA has sent the two companies a response letter indicating that there are still questions to be answered about the drug’s labelling and manufacturing processes.
In February the FDA extended its deadline for reviewing the application for the product, which is expected to be marketed under the Bydureon brand name, because adverse weather had closed its offices for five days over the winter.
However, there are no indications that the agency will ask for any new preclinical or clinical data, and Amylin chief executive Dan Bradbury expects to be able to respond to the queries within “a few weeks”.
The FDA inspected a manufacturing facility in Ohio that will make Bydureon last December and did indicate some issues that needed to be addressed. However, all of these concerns have been covered in responses sent to the agency and are not covered in the latest letter, according to Bradbury.
“Importantly, we have a clear path forward to approval,” he told analysts and reporters on a conference call on Monday (March 15). “We remain confident in our submission and are working diligently to prepare our response.”
The labelling issues detailed in the FDA’s letter relate to finalising details of the risk evaluation and mitigation strategy (REMS) for Bydureon, added Bradbury.
Amylin’s existing Byetta formulation of exenatide, co-marketed with Lilly, is already a big success story, accounting for the bulk of the Californian biotechnology firm’s $758 million revenues last year. In the past Bradbury has suggested that Bydureon could be a bigger product than Byetta in terms of sales potential.
Exenatide was the first in a new class of type II diabetes medicines called glucagon-like peptide-1 (GLP-1) analogues, and has been on the US market as a twice-daily injection since 2005. It is used in combination with oral diabetes medications such as metformin and sulfonylurea drugs to improve blood sugar control.
The Byetta formulation is now experiencing competition from Novo Nordisk’s Victoza (liraglutide), a once-daily GLP-1 analogue approved by the FDA in January and on the market in Europe since mid-2009.
Another potential rival in development is GlaxoSmithKline’s Syncria (albiglutide) which, if successful, may need to be injected less frequently than once a week. Syncria’s point of difference from the other GLP-1 analogues is that it fuses human GLP-1 to human albumin.
Bradbury also said Amylin is about to embark on a 9,000-patient cardiovascular outcomes study of the new formulation.
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