The most anticipated drug approvals in 2024

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Hi all,

I want to invite you to share information about upcoming drug approvals that you are waiting for. Last year ended with FDA approval for the first CRISPR treatment for sickle cell disease. What’s next?

Personally, I am very curious if Eli Lilly’s donanemab for Alzheimer’s disease will manage to finally get approval. In fact, this drug has been anticipated to launch for the past two years and last year it was close to FDA approval. Unfortunately, it is due to Biogen’s Aduhelm failure that subsequent drugs for Alzheimer’s disease have to face many challenges in obtaining approval.

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I’m looking forward to the FDA’s decision on KarXT, a new schizophrenia medication. If approved, it will be the first-in-class treatment for decades.

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For me - ensifentrine (dual inhibitor of PDE3 and PDE4). If approved it will be the first novel mechanism of action available for the maintenance treatment of COPD in more than 10 years. Approval is exected in June 2024

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I would add imetelstat to that list. If approved, imetelstat would be a first-in-class telomerase inhibitor, indicated for the treatment of transfusion-dependent anemia in patients with myelodysplastic syndromes (MDS). The company’s plan is to get initial approval for lower-risk MDS and expand into intermediate-2 or high-risk.

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Last week (6/6/2024) FDA approved imetelstat for low and intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia.

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Hi all,

Drug approval update:

  • donenemab (Kisunla) was approved by the FDA at the beginning of July
  • ensifentrine (Ohtuvayre) was approved by the FDA at the beginning of June