The agency granted full approval to pemetrexed for injection (Pemfexy), a liquid injection and branded alternative to Alimta, for nonsquamous NSCLC.
The FDA granted full approval to pemetrexed (Pemfexy), a liquid injection and branded alternative to Alimta, for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC), according to Eagle Pharmaceuticals.
The injection is a ready-to-dilute formulation indicated for the following:
This conversion from tentative approval-granted in 2017, but at the time was not eligible for marketing in the U.S. because of existing patent protections-to final approval is followed by the company’s settlement agreement with Eli Lilly and Company, which allowed for the initial entry of pemetrexed for injection into the market on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.
“We are pleased to receive final approval from (the) FDA and look forward to making Pemfexy available to the patients who can benefit. Our initial market exclusivity for PEMFEXY represents a significant opportunity for Eagle and builds on the successes of our expanding presence in the oncology space,” Scott Tarriff, chief executive officer of Eagle Pharmaceuticals, said in a press release.
With full approval, Eagle Pharmaceuticals has exclusive rights to commercialize the product for 4 months beginning February 1, 2022.
Eagle Pharmaceuticals. Eagle Pharmaceuticals Recieves Final FDA Approval for Pemfey™ (Pemetrexid for Injection). Published February 10, 2020. investor.eagleus.com/press-release/eagle-pharmaceuticals-receives-final-fda-approval-pemfexy-pemetrexed-injection. Accessed February 10, 2020.