Klisyri for Actinic Keratosis, MDMA for PTSD, Arexvy for RSV, Rytelo for MDS, Firdapse for LEMS

New FDA Approvals

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Visit learnAMAstyle.com for free downloads on medical writing and editing Klisyri for Actinic Keratosis: The FDA has approved tirbanibulin (Klisyri) for treating actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm². Previously approved for areas up to 25 cm² in December 2020, tirbanibulin is now available in a 350 mg package size for a 5-day topical treatment. Actinic keratosis is the most common pre-cancerous dermatological condition in the US, and this approval was based on a Phase 3 clinical study showing consistent safety and effectiveness for larger treatment areas.

MDMA for PTSD: An FDA advisory panel voted 10-1 against endorsing MDMA for PTSD treatment due to flawed study data, questionable research practices, and significant drug risks. The FDA will make its final decision on August 11, but the panel's negative feedback might influence a denial. This decision could impact the approval and acceptance of other psychedelics like LSD and psilocybin for medical use.

Arexvy for RSV: The FDA has approved the RSV vaccine AREXVY for preventing RSV lower respiratory tract disease in adults aged 50-59 at increased risk. Initially approved in May 2023 for adults aged 60 and older, AREXVY combines a recombinant RSV glycoprotein with an adjuvant. The approval followed a Phase III trial showing the vaccine's immune response and safety in the targeted age group.

Rytelo for MDS: The FDA has approved imetelstat (RYTELO) for treating low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia. Imetelstat, a telomerase inhibitor, demonstrated significant improvements in transfusion independence and hemoglobin levels in the IMerge Phase 3 trial. The approval was granted to Geron Corporation.

Firdapse for LEMS: The FDA has approved an increased dose of amifampridine (Firdapse) from 80 mg to 100 mg for treating Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients over 45 kg. Initially approved in 2018 for adults, and expanded to include children as young as 6 in 2022, the increased dose approval was based on clinical trials showing significant improvements in muscle strength. The approval was granted to Catalyst Pharmaceuticals.

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