Biogen Idec reported that its experimental MS drug peginterferon-1a hit its Phase III target and the company expects to put the therapy up for regulatory scrutiny in the US and EU this year. The trial showed that the long-acting medication was effective when patients received it either twice a month or once a month, although the bi-monthly shot had a bit of an edge. ISI analyst Mark Schoenebaum wrote in a research note that an approval would give Biogen Idec a significant advantage in the MS marketplace because the dosing would be far less than that of competitors which currently require at least a weekly dose. He also pointed out that since a flu-like feeling is a common side effect, reducing the number of doses goes beyond convenience and is also a matter of patient comfort.
A call for additional data has prompted Novartis Europharm to pull its EMA application for PAH drug Ruvise. The company submitted in February 2012, but said in a statement that it could not deliver the additional data by the regulator’s deadline.
Genentech won FDA approval to couple Avastin with chemotherapy for metastatic colorectal cancer patients. The indication means patients can prolong their Avastin therapy beyond the initial treatment stage. The FDA approved the indication based on Phase III studies which showed the risk of death fell 19% and median overall survival was 11.2 months, compared to 9.8 months among patients who only used the drug with chemotherapy as a first-line treatment. The indication could provide an added sales boost to what is already Genentech’s second-highest earner. The latest figures show the drug earned $3.4 billion in sales for the first six months of 2012 and $6 billion in 2011. The new indication also marks a claw-back of sorts: the FDA revoked its metastatic breast cancer indication in November 2011.
