Will Mirabegron Pass Muster In Overactive Bladder?
This article was originally published in The Pink Sheet Daily
Astellas aims to muscle in to a growing disease space dominated by muscarinic receptor agonists with its beta-3 agonist mirabegron (YM178) – but first it must get by an FDA advisory committee review.
You may also be interested in...
Astellas is on the verge of significantly increasing its heretofore small presence in oncology in the U.S. and abroad as it, along with its partners, prepares to file one and possibly two NDAs, including for the promising prostate cancer treatment MDV3100.
TOKYO - Astellas provided an update on development for blockbuster-hopeful mirabegron, and the main theme of its progress appears to be safety, or rather waiting for safety data. The company delayed U.S. and EU filings for the drug on regulatory requests for more safety data to assess cardiovascular risk. The company rescheduled mirabegron's FDA filing for 2Q/FY2011, and now everyone is waiting for full results on additional safety studies
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.