BMS, AbbVie land Breakthrough label

Share this article:

Bristol-Myers Squibb and AbbVie pocketed a Breakthrough Therapy designation for the experimental multiple myeloma medication elotuzumab.

The companies announced the expedited FDA review classification of their monoclonal antibody Monday. The experimental drug is being investigated for use in tandem with lenalidomide and dexamethasone for patients who have already received at least one or two rounds of prior therapy.

The companies said the FDA handed over the label based on open-label Phase-II data.

BMS and AbbVie are co-developing the drug, and BMS is taking the lead on its commercialization.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.

Study says statins not enough for diabetic hearts

Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.