(Reuters) – An experimental drug developed by argenx SE led to improvements in daily activities, including chewing and swallowing, in patients suffering from a muscle-weakening autoimmune disease, according to data published in the Lancet Neurology medical journal on Wednesday.
The late-stage study met its main goal of demonstrating that a greater percentage of patients on the treatment showed improvement in their daily activities compared to those on placebo.
The study enrolled 167 participants to evaluate argenx’s lead drug, efgartigimod, which seeks to reduce a type of disease-causing antibodies commonly found in patients with the chronic, rare autoimmune disorder called generalized myasthenia gravis.
Patients with myasthenia gravis suffer from muscle weakness that can affect daily activities including eye movement, facial expression, chewing, talking and swallowing.
Top-line results from the study were published https://www.argenx.com/news/argenx-announces-positive-topline-phase-3-adapt-trial-results by argenx in May last year.
At enrollment, despite ongoing myasthenia gravis therapy, patients still had poor scores on the myasthenia gravis strength and function scales. Treatment with efgartigimod provided significant, clinically meaningful, and durable clinical benefit to most of these patients, the study’s authors said in the journal.
The application for the drug is currently being reviewed by the U.S. Food and Drug Administration (FDA) and the agency is scheduled to take a decision on the drug’s approval by Dec. 17, the company said.
If approved, the drug will compete with treatments such as Alexion Pharmaceutical’s FDA-approved drug Soliris, which works by suppressing a part of the body’s immune system said to play a role in the disease. AstraZeneca Plc in December agreed to buy Alexion for $39 billion.
Existing treatments for generalized myasthenia gravis are associated with burdensome short- and long-term side effects that can limit their use, according to the journal.
Autoimmune myasthenia gravis has a prevalence of about 14 to 40 per 100,000 individuals in the United States, according to patient advocacy group, the National Organization for Rare Disorders.
(Reporting by Amruta Khandekar and Manojna Maddipatla in Bengaluru; Editing by Vinay Dwivedi)
