Eli Lilly and Amylin moved a step closer to securing European Medicines Agency approval for their fast-growing drug Byetta yesterday, after the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on its use in patients with type 2 diabetes.
The CHMP also backed approval of Bristol-Myers Squibb’s Sprycel (dasatinib) for the treatment of chronic myeloid leukaemia in patients with resistance or intolerance to prior therapy including Novartis’ Glivec (imatinib mesylate), and acute lymphoblastic leukaemia in patients with resistance or intolerance to prior therapy.
Byetta (exenatide) is an incretin mimetic that is an add-on therapy, used in patients with type 2 diabetes whose blood glucose levels aren’t controlled with oral diabetes agents such as metformin or sulfonylureas. Studies have shown that it is as effective as twice-daily insulin in these uncontrolled patients.
Byetta looks set to be a major new product for Lilly and Amylin, racking up $99 million in sales for Lilly in the second quarter of 2006, despite only being launched in June 2005 and held up by manufacturing constraints that have since been resolved.
Meanwhile, Sprycel’s positive opinion is a boost for B-MS, still reeling from the start of generic competition to its flagship antithrombotic Plavix (clopidogrel) and the sacking of chief executive Peter Dolan.
Sprycel, which is already on the market in the USA, is considered a major new product for the group, as it should provide the first treatment option for the 30% of patients with CML who fail to respond to Glivec, itself a blockbuster product.
Analysts have suggested it could achieve sales of around $500 million a year, potentially becoming a blockbuster product if its indications are expanded to include first-line treatment of leukaemia or other cancer indications. Novartis reported worldwide Glivec sales of $2.2 billion last year.