Sarepta allowed to continue US Elevidys shipments
It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome development.
29 July 2025
29 July 2025
It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome development.
Despite being significantly lower than the 200% rate threatened by Trump, the deal is set to ramp up drug costs by billions.
The approval of Skytrofa for adults with GHD was based on the findings from the foresiGHt trial.
This 15.6% CAGR is largely attributed to the launch of novel biologics and small molecules.
The total value of the deal exceeds $1bn for the first three targets, in addition to royalty payments based on net sales.
Alfasigma is in discussions with the EMA and MHRA about Jyseleca for axSpA but has yet to reveal any plans for US submission.
The CHMP positive recommendation comes a month after the WHO backed the drug for global HIV prevention.
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