Samuel Hume: The FDA approved 7 new drugs in June/July – what were they?
Samuel Hume, previous PhD at University of Oxford, shared on X:
“The FDA approved 7 new drugs in June/July – what were they?
1. Donanemab, an antibody which clears amyloid plaque and slowed clinical progression of early Alzheimer’s in a clinical trial.
2. The first telomerase inhibitor to be approved, Imetelstat – for use in myelodysplastic syndromes In trials of patients who are unresponsive to erythropoiesis-stimulating agents, Imetelstat provided a subset with independence from blood transfusions.
3. The PDE3/4 inhibitor, Ensifentrine, for chronic obstructive pulmonary disease (COPD), which updates options for COPD that have been similar for >40 years.
In trials, Ensifentrine improves lung function and reduces COPD exacerbations.
4. Sofpironium, the second topical anticholinergic to be approved for excessive underarm sweating (primary axillary hyperhidrosis).
In trials, Sofpironium reduces sweating and improves symptoms.
5. The complement C5 inhibitor, Crovalimab, for paroxysmal nocturnal haemoglobinuria, which causes anaemia due to the breakdown of red blood cells.
In trials, Crovalimab was just as good as Eculizumab (also a C5 inhibitor) but Crovalimab doesn’t need regular infusions.
6. The PPAR α/δ agonist, Elafibranor, for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid – the only previously approved first-line therapy.
Elafibranor improves PBC based on blood tests, like ALP.
7. Deuruxolitinib, a JAK inhibitor for severe alopecia areata, adding to the other FDA-approved JAK inhibitors, Bariticinib and Ritlecitinib In trials, Deuruxolitinib boosts hair regrowth and patient satisfaction.
Imetelstat for myelodysplastic syndromes.
Ensifentrine for COPD.
Sofpironium for primary axillary hyperhidrosis.
Crovalimab for paroxysmal nocturnal hemoglobinuria.
Elafibranor for primary biliary cholangitis.
Deuruxolitinib for severe alopecia areata.”
Source: Samuel Hume/X