Roche Secures FDA Approval for Subcutaneous Ocrevus and Tecentriq, Lilly Gains Approval for Eczema Treatment
Roche's Approvals:
Ocrevus Zunovo:
The FDA approved Ocrevus Zunovo, a subcutaneous injection for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). It is administered twice a year in a 10-minute injection.
Tecentriq:
Roche also gained FDA approval for a subcutaneous version of Tecentriq, though specific details on its indications are not provided in the given sources.
Lilly's Approval:
Eczema Treatment:
Lilly secured FDA approval for a treatment for atopic dermatitis (eczema), though the specific product name is not mentioned in the provided sources. A related study on lebrikizumab showed significant skin improvement in patients with atopic dermatitis and skin of color.
Other Recent Approvals:
Sun Pharma’s Leqselvi:
Approved for treating severe alopecia areata, an autoimmune disease causing hair loss. The approval was based on two Phase III trials showing significant scalp hair coverage improvements.
BioMarin’s Brineura:
Expanded approval for treating neuronal ceroid lipofuscinosis type 2 (CLN2) disease in children of all ages, whether symptomatic or presymptomatic.
Takeda’s Entyvio SC:
Approved for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction therapy with intravenous Entyvio.
AstraZeneca’s Fasnera:
Label expansion for treating severe eosinophilic asthma in children aged 6 to 11 years.