…… catching up o FDA approvals
The FDA has approved a new specialty topical gel, Filsuvez (birch triterpenes) from Chiesi Farmaceutici S.p.A. Parma, indicated for the treatment of the rare, devastating skin disease epidermolysis bullosa (EB).
EB is a genetic, connective tissue disease that causes the skin to become fragile and blister. The condition can worsen to be life-threatening including the development of aggressive squamous cell carcinomas and infections.
The overall incidence and prevalence of EB are 19.6 and 11.07 cases per million live births, respectively. The incidence and prevalence of junctional epidermolysis bullosa are estimated at 2.68 and 0.49 cases per one million live births.
Chiesi has not published acquisition pricing. However, they have confirmed that PANTHER Rx Rare was selected as a limited distribution partner for Filsuvez.
CLICK HERE for prescribing information
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After Amryt buyout, Chiesi scores with FDA nod for rare skin disease treatment Filsuvez
The FDA’s approval of rare skin disease drug Filsuvez gives Chiesi Global Rare Diseases its third nod for a new drug from the U.S. regulator this year. (Chiesi)
Seven months after Krystal Biotech became the first company to gain FDA approval to treat, Chiesi Farmaceutici has followed suit.
