Posted on 19/08/2010 in Pharmaceutical Company Product News Bristol-Myers Squibb reported progress in its application for regulatory approval of its new drug ipilimumab, a therapy for advanced melanoma patients.
The US Food and Drug Administration has accepted the company's biologics licence application for the treatment for filing and review, as well as granting the drug priority review status.
This decision was taken based on positive clinical trial data from the recent MDX010-020 study, as well as the fact that there is currently a lack of available therapies for this condition.
It comes as Bristol-Myers Squibb seeks to secure approval for the compound as a treatment for previously-treated adult patients from a number of global healthcare regulators, including the European Medicines Agency.
The company hopes ipilimumab can prove to be a viable new option for use against melanoma, a condition which has rapidly increased in incidence in the last 50 years.
This week, Bristol-Myers Squibb is attending the International Congress of the Transplantation Society, where it is presenting new clinical data on the drug belatacept. Other news stories from 19/08/2010
Read more in the Zenopa News Archive
How this news is generated
|
