Biotech company Regeneron (REGN) and French pharmaceutical giant Sanofi (SNY) today announced that Japan has granted marketing and manufacturing authorization for their Dupixent treatment for chronic obstructive pulmonary disease (COPD).
Approval marks the first new treatment approach for COPD, the name of a group of lung conditions often associated with smoking or asthma, in more than a decade in Japan, the drugmakers said in a joint statement.
Following recent approvals in the European Union, China and the U.S., the approval in Japan was based on key Phase 3 trial results in adults with elevated eosinophils, white blood cells that play a key role in the body’s immune system.
The drug was created using REGN’s proprietary VelocImmune Technology, which uses genetically engineered mice endowed with a “humanized immune system” to produce human antibodies.
Regeneron won approval from the U.S. Food and Drug Administration (FDA) last year, making it the first biologic medicine approved in the U.S. for the treatment of COPD. In November 2024, the European Commission approved Dupixent to treat eosinophilic esophagitis, a type of inflammation of the esophagus that makes breathing difficult, in children aged 1 to 11 years, making it the first and only medicine for young patients suffering this condition.
Last month REGN said 2024 Dupixent global net sales increased 22% to $14.15 billion as it won approval for its treatment of COPD around the world.
Is REGN a Good Stock to Buy?
REGN has a Strong Buy consensus rating based on 20 Wall Street analysts offering 12-month price targets for Regeneron in the last three months. The average price target is $956.25 with a high forecast of $1,182.00 and a low forecast of $575.00. The average price target represents about 50% upside.
