Ironwood Pharmaceuticals Inc. said in a Friday press release that a committee that advises European regulators has issued a positive opinion on its treatment for a form of irritable bowel syndrome, or IBS.
The opinion by the European Committee for Medicinal Products for Human Use is one of the final steps in the review of a drug’s marketing authorization application. Cambridge-based Ironwood’s partner in Europe is Almirall.
The committee’s positive opinion is on the use of the drug to treat adults that suffer from moderate to severe irritable bowel syndrome with constipation.
The marketing name of drug is Constella in Europe and Linzess in the US. The chemical name for both is linaclotide.
Ironwood recently won approval from the US Food and Drug Administration to market its new drug to treat irritable bowel syndrome with constipation in the US.
Because IBS afflicts 30 to 40 million Americans, linaclotide has the potential to be a blockbuster drug with annual sales of $1 billion or more.
To read a recent Globe article about Ironwood and its IBS drug, please click here.