LANNETT ANNOUNCES FDA COMPLETES REVIEW OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR BIOSIMILAR INSULIN GLARGINE
Lannett Company (NYSE: LCI) announced that the FDA has completed its safety review of the IND application for its biosimilar insulin glargine, allowing the company to proceed with clinical trials. The pivotal trial is expected to start by March 2022 and conclude by early 2023. CEO Tim Crew stated that successful results could lead to a BLA filing in early 2023 and a product launch by early 2024. The trial will take place in South Africa, utilizing the final formulation for the biosimilar insulin glargine.
- FDA approval to proceed with the clinical trials for biosimilar insulin glargine.
- Pivotal clinical trial set to commence by March 2022, signaling progress in product development.
- Potential for filing the BLA in early 2023 and launching the product by early 2024.
- None.
PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New Drug (IND) application for biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC), and concluded that the company may proceed with the proposed clinical investigation. The company said it anticipates the pivotal clinical trial to commence by March 2022 and be completed by early 2023.
"We are on track to initiate the dosing of subjects later this quarter," said Tim Crew, chief executive officer of Lannett. "If the trial is successful, we would anticipate filing the Biologics License Application (BLA) in early 2023 and, if then approved, potentially launching the product by early 2024. Biosimilar insulin glargine is a key product in our durable product pipeline; we look forward to bringing this critically important and more affordable biosimilar medicine to the large and growing number of patients living with diabetes."
Crew added, the clinical trial will be conducted in South Africa at the same site and use the same clinical design as the previously completed first human volunteer pilot study. With FDA's review of the IND, the necessary regulatory clearances (both in the U.S. and South Africa) to conduct the study have been received. The pivotal trial will be conducted using the proposed final to-be-marketed formulation of the Lannett/HEC biosimilar insulin glargine.
Lantus® is a registered trademark of Sanofi S.A.
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, advancing the development of biosimilar insulin glargine, as well as timing and outcome of the pivotal clinical trial, FDA approval and successfully commercializing the product, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.
Contact: | Robert Jaffe |
Robert Jaffe Co., LLC | |
(424) 288-4098 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/lannett-announces-fda-completes-review-of-investigational-new-drug-ind-application-for-biosimilar-insulin-glargine-301465378.html
SOURCE Lannett Company, Inc.
FAQ
What did Lannett Company announce on January 21, 2022?
When is the pivotal clinical trial for Lannett's biosimilar insulin glargine expected to start?
What is the estimated timeline for Lannett to launch the biosimilar insulin glargine?
Where will the clinical trial for the biosimilar insulin glargine take place?
What is the significance of the FDA's approval for Lannett Company?
