Lyrica rejected for fibromyalgia by the CHMP

28 Apr 2009

• By John Davis

Pfizer's anticonvulsant, pregabalin (Lyrica), has received a negative opinion from the EU's CHMP for use in fibromyalgia, an additional indication. Benefits with pregabalin had not been shown in either the short or long term, the committee concluded.

This is the second time the CHMP has turned down a medicine for fibromyalgia in the past eight months. Last...

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New Regenxbio DMD Data Support Gene Therapy Accelerated Approval

05 Jun 2025

• By Joseph Haas

Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.

Wave Aspires To Accelerated Approval In DMD With 48-Week Data

26 Mar 2025

• By Joseph Haas

With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.

Regenxbio Rises After Duchenne Update And Sarepta Safety Scare

20 Mar 2025

• By Andrew McConaghie

Encouraging results in younger children with Duchenne is keeping Regenxbio on track for a potential mid-2026 filing for its gene therapy, RGX-202.

Sarepta Shares Plummet On News Of Elevidys Patient Death

18 Mar 2025

• By Joseph Haas

The gene therapy for Duchenne muscular dystrophy passed the blockbuster sales threshold in 2024. Analysts said the drug’s overall risk/benefit profile still appears solid.