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Congress may consider directing FDA to better assess the benefits and risks associated with gene therapy products over a prolonged period of time and the regulatory apparatus that exists to monitor and mitigate those risks.

Pfizer’s HYMPAVZI (marstacimab), FDA approved in October 2024 for adults and adolescents with Hemophilia A without inhibitors, has been steadily growing.

FDA approves Roctavian, the first adeno associated virus vector based gene therapy for the treatment of adults with severe hemophilia A.

Improvements in AAV technology, protein expression, and immunogenicity may make AAV mediated gene therapies more efficient, longer lasting, and safer for people with hemophilia A or B.

Hemophilia A and hemophilia B are genetic bleeding disorders caused by a dysfunction or deficiency of coagulation factor VIII (FVIII) or IX (FIX), respectively.

In October 2024, that day finally came. Krouse, now 57—with his parents by his side—was the first Penn Medicine patient to receive a new gene therapy for hemophilia B since it was approved by the FDA. It was the first FDA approved gene therapy for the condition in adults.

On June 29, 2023, FDA announced that it approved Roctavian (valoctocogene roxaparvovec rvox), an adeno associated virus vector based gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A. The therapy is indicated for adults without pre existing antibodies to adeno associated virus serotype 5 detected by an FDA approved test.

“Gene therapy for hemophilia has been on the horizon for more than 2 decades,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement about the treatment for adults with hemophilia B.

The advent of replacement therapy with FIX concentrates and recently approved no factor hemostatic agents has rendered great improvement in the quality of life for patients with hemophilia B ...

“Today’s approval provides a new treatment option for patients with Hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”

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