Amylin, Alkermes' Bydureon approved in US on third atttempt

Amylin and Alkermes' long-acting drug for type 2 diabetes Bydureon has been approved for marketing in the US at the third attempt.

The decision makes Bydureon (extended-release exenatide) the first once-weekly treatment for diabetes to be registered by the FDA, and the news that prolonged process to reach the US market had finally ended prompted a surge in Amylin's share price in after-hours trading.

Bydureon is already on the market in Europe after being approved there in 2010, but was delayed in the US while the FDA asked for additional information on how the extended-release formulation affected the heart.

It uses the same active ingredient as Amylin's twice-daily Byetta injection, which has been on the market since 2005, but uses a long-acting formulation developed by partner Alkermes.

Amylin recorded Byetta sales of $385m in the first nine months of 2011, with the product accounting for more than 80 per cent of its total turnover.

The US approval comes with a commitment to carry out a post-marketing study to determine whether Bydureon raises cardiovascular risk.

Meanwhile, Amylin has also agreed a Risk Evaluation and Mitigation Strategy (REMS) with the FDA that is designed to guard against acute pancreatitis which has been seen rarely with treatment, as well as the potential risk of medullary thyroid carcinoma.

Amylin is in the process of buying back rights to the exenatide franchise from Eli Lilly, which was its partner for the programme for more than a decade.

The two companies fell out after Lilly formed a partnership with Boehringer Ingelheim last year for Trajenta (linagliptin), a rival diabetes treatment.

After legal action they agreed a $1.6bn separation package, including an upfront severance payment to Lilly of $250m, with the US the first market in which Amylin will regain full control.

The company said it is planning to launch Bydureon in the US next month, and is currently looking for a new marketing partner for Bydureon outside the US market.

In the US it plans to go it alone and will be competing head-to-head with Novo Nordisk's rival Victoza (liraglutide), a once-daily drug in the same GLP-1 receptor agonist class that is growing fast.

A once-weekly version of liraglutide is also in the pipeline, with other long-acting GLP-1 agonists from the likes of GlaxoSmithKline and Lilly also due to reach the market over the next couple of years.