Abbott receives CHMP recommendation for new Humira indication

Abbott has been granted a recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for a new specification of its multipurpose TNF blocker Humira.

The European Medicines Agency committee has issued a positive opinion on the approval of the drug as a treatment for adults with moderate to severely active ulcerative colitis (UC) who are unable to benefit from conventional therapies.

Data from a pair of phase III trials has shown that Humira can deliver significant benefits in terms of clinical remission rates among these patients.

Should the drug be approved by the European Commission, it would become the first and only self-injectable biologic therapy available for moderate to severe UC patients.

Dr John Leonard, senior vice-president for pharmaceuticals research and development at Abbott, said: "Today's positive opinion is a step forward in making Humira available to patients with UC throughout the EU and underscores our longstanding commitment to patients with inflammatory bowel disease."

Earlier this month, the company announced that it will be expanding its capabilities at its Irish manufacturing site in Sligo, creating around 175 new jobs.