FDA approves Teva and Eagle's Bendeka

9 December 2015

Shares of Eagle Pharmaceuticals (Nasdaq: EGRX) leapt 14.4% to $93.70, after it was revealed that the US Food and Drug Administration had approved Bendeka (bendamustine hydrochloride) injection, a liquid, low-volume (50mL) and short-time 10-minute infusion formulation of bendamustine.

Bendeka, which has been developed in collaboration with Israel’s Teva Pharmaceutical Industries (NYSE: TEVA), is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

Under the February 2015 exclusive license agreement for Bendeka, Teva is responsible for all US commercial activities for the product including promotion and distribution. Teva expects to make Bendeka commercially available to prescribers during the first quarter of 2016.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK