Amylin, Eli Lilly and Alkermes said the FDA accepted their Bydureon resubmission and awarded a six-month review, extending the PDUFA date to January 28, 2012. The response, which follows two 2010 rejections, likely includes a recently completed tQT study, DURATION-5 study and an integrated safety update. In a recent note, Collins Stewart analyst Salveen Richter pointed out that in the UK, where the once-weekly type 2 diabetes treatment was approved in June, Bydureon has been priced below fellow GLP-1 drug Victoza, “potentially due to or to partially offset DURATION-6 headwinds,” in which Bydureon failed a non-inferiority test vs. the Novo Nordisk drug. “We remain cautious on the commercial viability of Bydureon.”
The FDA approved a one-pill, once-daily combination of Gilead's Truvada and Johnson & Johnson's Edurant HIV meds. Analysts anticipate that the pill, to be marketed as Complera, will achieve broad first-line use, despite having lower efficacy among sicker patients than the market leader, Gilead/BMS's combo pill Atripla, which had 2010 US sales of $2.2 billion, according to Wolters Kluwer Pharma Solutions wholesale acquisition cost data. Truvada, which is also an antiviral cocktail in a pill, garnered $1.69 billion in US sales.