Managed Healthcare Executive March 23, 2024
Denise Myshko

New approvals this week include a $4.25 million gene therapy, a drug that treats hypertension in a new way, a nonsteroidal drug for Duchenne, and an oral drug for aggressive leukemia. The agency has set an action date for resubmitted Lymphir in rare skin cancer, and Celltrion has launched Zymfentra, a subcutaneous form of infliximab.

New Gene Therapy for Rare MDL to Cost $4.25 Million

Orchard Therapeutics has set the wholesale acquisition cost of its newly approved gene therapy, Lenmeldy (atidarsagene autotemcel), at $4.25 million for the one-time treatment. Company officials in a press release said this price reflects its clinical, economic and societal value. Lenmeldy is the first approved gene therapy to treat children with juvenile metachromatic leukodystrophy (MLD),...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

 
Topics: FDA, Govt Agencies
FDA Approves First Biosimilar of Xolair
Opinion: STAT+: How will the Center for Biologics Evaluation and Research change under RFK Jr.?
How the FDA Opens the Door to Risky Chemicals in America’s Food Supply
FDA OKs First Gene Therapy Implant for a Rare Eye Disease
Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder

Share This Article