FDA approves novel therapy for chronic skin condition
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
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The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
If approved, Novartis’ remibrutinib has potential to be the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade.
With the addition of the new dermatology trials, Fasenra is now being evaluated in nine different indications associated with eosinophilic immune dysfunction.