FDA Accepts Regeneron, Sanofi's Filing For Review In Skin Disease

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for review submitted by Regeneron Pharmaceuticals REGN and Sanofi SNY for the lead drug candidate Dupixent (dupilumab) for the treatment of patients with prurigo nodularis.

The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of Sept. 30, 2022. 

The filing is supported by data readout from PRIME2 and PRIME pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis.

Prurigo nodularis is a chronic skin disease that causes extreme itch and inflammatory skin lesions (nodules).

The company said that additional regulatory filings around the world are also planned in 2022.

The FDA grants Priority Review that shortens review period of BLA, applicable for medicines which may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.

Regeneron shares are trading down 4.14% at $664.12. 

Posted In: FDA ReviewBiotechNewsHealth CareFDAMoversTrading IdeasGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.