Eagle Pharmaceuticals Gets FDA Approval for New Pemfexy Indication

By Chris Wack

Eagle Pharmaceuticals Inc. said Monday that the U.S. Food and Drug Administration has approved an additional indication for Pemfexy pemetrexed injection.

The company said the new indication is in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no genomic tumor aberrations.

Eagle's approved Pemfexy is a ready-to-dilute novel liquid intravenous formulation developed to eliminate the reconstitution step of the listed drug, Alimta.

Effective Oct. 1, the company amended its agreement to reduce future royalties related to Pemfexy profits from 25% to a range of 0% to 12.5%, based on profits achieved in exchange for a one-time payment of $15 million.

In February 2020, Eagle received approval from the FDA of its New Drug Application for Pemfexy, following the settlement agreement of patent litigation with Eli Lilly and Co. in December 2019.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

December 19, 2022 07:19 ET (12:19 GMT)

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