Plus   Neg

Sanofi Says FDA To Review Meningococcal Vaccine Candidate MenQuadfi

French pharma major Sanofi (SNYNF,SNY) announced Thursday that the U.S. Food and Drug Administration has accepted for review the Biologics License Application or BLA for MenQuadfi, a meningococcal vaccine candidate. The target action date for the FDA decision is April 25, 2020.

The company noted that the BLA is for MenQuadfi Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis.

Sanofi's recently submitted BLA includes positive data from Phase II and Phase III clinical trials held in the U.S. to seek an indication for use of the vaccine in persons 2 years of age and older. If approved, MenQuadfi will be available in a fully liquid presentation.

The company has performed Phase II and Phase III trials in the U.S., the European Union, Asia and Latin America. Sanofi is conducting additional Phase III trials in these same regions and Africa.

MenQuadfi's safety and efficacy data have not yet been evaluated by any regulatory authority.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Food and Drug Administration or FDA announced on its website that pharma major Pfizer, Inc. issued recall of two lots of tablets meant to treat acute migraine in adults for concerns over bacteria infection. The pharma company is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets for potential presence of Genus Pseudomonas and Burkholderia bacteria. Cosmetics company Revlon Inc. (REV) is reportedly considering a potential sale of parts or all of its business. According to Bloomberg, Revlon has retained financial advisers from Goldman Sachs Group Inc. to explore strategic alternatives. No deal has been reached yet, but Revlon is exploring all... China's Lenovo Group Ltd. warned it may have to raise prices of its products if the U.S. moves ahead with the decision to impose additional tariffs on Chinese goods, according to a report by Reuters. The warning by Lenovo, the world's largest PC maker, comes amid the escalating trade war between the U.S. and China that has raised concerns about the global economic outlook.
Follow RTT