Restrictions on use of modafinil for sleep disorders recommended in EU

The EU's CHMP has recommended restricting the use of modafinil-containing medicines to the treatment of sleepiness associated with narcolepsy because of concerns over safety that are already largely reflected in product labelling - including neuropsychiatric disorders and skin and subcutaneous tissue reactions - which it said did not outweigh its benefits in other approved indications.

The EU's CHMP has recommended restricting the use of modafinil-containing medicines to the treatment of sleepiness associated with narcolepsy because of concerns over safety that are already largely reflected in product labelling - including neuropsychiatric disorders and skin and subcutaneous tissue reactions - which it said did not outweigh its benefits in other approved indications.

Medicines containing modafinil, a wakefulness promoting agent that is thought to interact with neurotransmitters in the brain such as dopamine...

More from Cardiovascular

Mineralys Eyes NDA As Lorundrostat Scores CKD Win In Race With AstraZeneca

 

As it races AstraZeneca’s baxdrostat to market, Mineralys plans to file an NDA later this year, backed by strong efficacy and safety data across four trials.

Merck & Co.’s Winrevair Positioned For Expansion On HYPERION Results

 

The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.

Obesity Treatment Could Go Global With Lilly’s Orforglipron

 

The company’s oral GLP-1 candidate has reassured on its safety at the American Diabetes Association meeting, convincing analysts it will open up new global markets.

Lilly Agrees To Acquire PCSK9 Base-Editing Partner Verve

 
• By 

Instead of opting in on Phase II-ready PCSK9-targeted VERVE-102, Lilly will buy its partner for up to $1.3bn. Analysts call the deal a bargain for Lilly, but fair to Verve.

More from Therapeutic Category

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By 

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.