AstraZeneca’s Soliris Wins EU Recommendation In Pediatric gMG As Competition Looms

Addressing Unmet Need

26 Jun 2023

• By Ayisha Sharma

The UK major’s older C5 inhibitor product could soon receive EU approval for children and adolescents with the rare disease, but emerging competition from biosimilar developers and rival firms are starting to stack up.

Alexion/AstraZeneca PLC’s Soliris has been recommended for EU authorization in children and teenagers with refractory anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalized myasthenia gravis (gMG) – a small but challenging subset of patients – even as its broader C5 franchise faces significant external threats.

Soliris (eculizumab) first won an EU thumbs up in adult patients with the rare and debilitating neuromuscular disease that leads to loss of muscle function and severe weakness in 2017 and has

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Pipeline Watch: Eight Approvals And Nineteen Phase III Readouts

19 May 2025

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In Brief: US FDA Delay Sends Biohaven Shares Down

16 May 2025

• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

13 May 2025

• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

12 May 2025

• By Andrew McConaghie

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

First Blood-Based Test Cleared For Alzheimer’s Boosts Anti-Amyloid Drugs

19 May 2025

• By Mandy Jackson

The US FDA approval of Fujirebio’s Lumipulse should boost access to medicines like Eisai’s Leqembi and Lilly’s Kisunla; the firms are praising patients’ access to earlier diagnoses.