Investigations into Crovalimab drug trial compensation claim after participant’s nerve damage diagnosis

The drug is being prepared for market in the UK as part of disease modifying treatment for patients with a rare blood disorder known as paroxysmal nocturnal hemoglobinuria (PNH).  

In April 2022, the woman, who we have called Lucy, was enrolled in a Phase III open-label clinical trial testing the efficacy of trial drug crovalimab in treatment of patients with underlying PNH. 

During the trial, Lucy became increasingly unwell, was admitted to hospital with nausea, vomiting and chronic pain in her hands. This resulted in her being advised to discontinue the trial. 

Following the trial, Lucy’s symptoms persisted. She was referred to a neurologist and subsequently diagnosed with mononeuritis multiplex, a form of nerve damage which has caused her chronic pain in her hands and sensory disturbances in her limbs. The injuries she sustained have left her unable to undertake some basic daily tasks and unable to work.

Crovalimab is a strong monoclonal antibody drug which aims to reduce the destruction of red blood cells (haemolysis) in patients with PNH. The drug trial, which also tested the transition to crovalimab from already approved drug Soliris, was sponsored by a large pharmaceutical company and is still active. It is expected to be completed in June 2028.

Until 2024, crovalimab was not approved for the treatment of PNH in any country. The drug has since been approved for the treatment of PNH in China (in February 2024), Japan (in April 2024), with approval in the US by the Food and Drug Administration (FDA) being given in June 2024. The drug carries a black box warning in the US - the highest safety-related warning that medications can have assigned by the FDA.

In the UK, the drug is still yet to be approved for treatment in patients with PNH, but approval from the National Institue for Health and Care Excellence has been sought with a decision expected in October 2024.  

Lucy instructed the clinical trials team at Leigh Day to investigate a claim for compensation for the injuries she suffered and her resulting financial losses. Leigh Day is pursuing a claim under the Association of the British Pharmaceutical Industry compensation guidelines.  

The clinical trials team at Leigh Day also understands that other individuals may have suffered adverse reactions following treatment with crovalimab.  

Leigh Day Partner Gene Matthews said: 

“The injuries that our client has received have severely impacted her life and left her unable to work. Our team is investigating the potential for compensation for these injuries and understands that others may have been affected by the same drug. Those affected individuals may wish to seek independent legal advice”. 

If you have been harmed following your participation in a clinical trial you can contact the clinical trial team using the following details: Gene Matthews (gmatthews@leighday.co.uk) or Frances Clark (fclark@leighday.co.uk).