FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE) February 10, 2020 -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has received final approval from the U.S. Food and Drug Administration (“FDA”) for its novel product, Pemfexy (pemetrexed for injection), a branded alternative to Alimta®.
“We are pleased to receive final approval from 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,” stated Scott Tarriff, Chief Executive Officer.
The conversion from tentative to a final approval follows the Company’s settlement agreement reached with Eli Lilly and Company (NYSE: LLY) (“Lilly”) on December 13, 2019. This agreement provides for a release of all claims by the parties and allows for an initial entry of Pemfexy into the market (equivalent to approximately a three-week supply of current Alimta utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.
The Company received tentative approval for Pemfexy in 2017, reflecting FDA’s conclusion that the product met all required quality, safety and efficacy standards, but at the time was not eligible for marketing in the U.S. because of existing patent protections.
Pemfexy is a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. (Article from : www.drugs.com)