The FDA has given Sanofi’s hemophilia A drug BLA the Priority Review Status.

Sanofi

Sanofi (NASDAQ:SNY)

Sanofi (NASDAQ:SNY) has announced that the Food and Drug Administration (FDA) has granted priority review to its biologics license application (BLA) seeking approval of its novel recombinant factor VIII therapy, efanesoctocog alfa (BIVV001), for the treatment of people who have hemophilia A. This therapy is intended to prevent the development of hemorrhagic complications in patients. On February 28, 2023, it is anticipated that the FDA will make a decision regarding the BLA.

Efanesoctocog alfa is being developed and brought to market in a partnership between Sanofi (NASDAQ:SNY) and Swedish Orphan Biovitrum (Sobi).

So far this year, the fall in Sanofi (NASDAQ:SNY) shares is 18.8%, which is significantly higher than the industry decline of 1.6%.

The data from the XTEND-1 pivotal phase III research, which evaluated efanesoctocog alfa in previously treated adults and adolescents with severe hemophilia A, a rare genetic condition, served as the foundation for the BLA filing. Based on an intra-patient comparison, the study found that therapy with efanesoctocog alfa resulted in a clinically relevant reduction in the number of bleeds that were experienced and showed superiority to the use of previous factor prophylaxis. According to the findings of the study, efanesoctocog alfa caused a decrease in annualized bleeding rates.

Both the Breakthrough Therapy and Orphan Drug designations have been bestowed upon efanesoctocog alfa by the Food and Drug Administration. Next, the release of data from an ongoing pediatric trial known as XTEND-Kids, a regulatory application, is anticipated to be submitted in Europe the following year.

In addition to efanesoctocog alfa, Sanofi has another pipeline candidate in the form of fitusiran. This candidate is now undergoing late-stage research to treat uncommon genetic disorders such as hemophilia A and B.

In June, the drug combination Xenpozyme/olipudase alfa was approved in Europe for treating patients suffering from non-Central Nervous System manifestations of acid sphingomyelinase deficiency (ASMD). This genetic disease is rare, progressive, and has the potential to be fatal. In Japan, Xenpozyme has already been granted approval for treating ASMD. In the United States, an application seeking approval for olipudase alfa is now being reviewed, and a decision on the application is anticipated within the next couple of months.

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