FDA Action Alert: Sarepta, Protalix, Otsuka/Lundbeck and More

[{"selector":"#anim-e1b7a1be-7786-45ca-a317-9b423731d88a","keyframes":{"opacity":[0,1]},"delay":0,"duration":1200,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] [{"selector":"#anim-09420d87-1c07-444c-8945-b0ae4f72e2a6","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

1. The FDA has three target action dates and three advisory committee meetings in May, including one for an investigational gene therapy.

[{"selector":"#anim-57dc75e3-def7-4590-88a4-8d058b1f9bde","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

2. Eyenovia's MydCombi, a drug-device product, is awaiting FDA approval for inducing in-office pupil dilation.

[{"selector":"#anim-e462105a-67fd-4a18-be10-6deab8f1bea4","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

3. Protalix BioTherapeutics and Chiesi Global Rare Diseases await the FDA's decision on PRX-102, a treatment for adult patients with Fabry disease.

[{"selector":"#anim-35d4bc53-afcf-4b0b-8afc-0cd12151ebf0","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

4. Otsuka and Lundbeck seek FDA approval to expand Rexulti's label to include agitation associated with Alzheimer's disease.

[{"selector":"#anim-1529173f-bbd1-4a4d-abb3-9c9c0eb13b90","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

5.. HRA Pharma's Opill, a birth control tablet, could become the first daily pill available without a prescription if approved by the FDA.

[{"selector":"#anim-0904d974-6b09-4305-bb8f-2ea1785b85dc","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

6. The FDA will discuss ARS Pharmaceuticals' epinephrine nasal spray, Neffy, intended for emergency treatment of type 1 allergic reactions.

[{"selector":"#anim-5fb87142-1402-4634-9dfa-1ea0cf2fec57","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

7. Neffy could become the first non-injectable epinephrine product for allergic reactions in the US if approved.

[{"selector":"#anim-a1de8a95-5cb5-4dee-883a-1f2cbfb05edc","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

8. Sarepta's investigational gene therapy, Delandistrogene Moxeparvovec, for Duchenne muscular dystrophy (DMD) faces an FDA advisory committee meeting.

[{"selector":"#anim-72e5ee7e-6e43-4dfc-8ffe-c69ba4835868","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

9. If approved, Delandistrogene Moxeparvovec would be the first gene therapy for DMD.

[{"selector":"#anim-a13d3eb6-a1b2-4c4f-9301-1be22ab12ba5","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

10. The FDA's target action date for Sarepta's gene therapy is May 29, 2023.

[{"selector":"#anim-9622156a-f428-40e1-b147-dc5119f3115a","keyframes":{"opacity":[0,1]},"delay":0,"duration":2500,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Gray Frame Corner Gray Frame Corner

Swipe up for more BIOMARKER news!

[{"selector":"#anim-050fa697-8453-4df1-a4e4-052aa29734a9","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] Learn more