Celgene's thalidomide drug cleared for use in EU

Mon Apr 21, 2008 11:05pm BST
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LONDON (Reuters) - Thalidomide, which caused birth defects when it was launched as a morning sickness pill half a century ago, has been officially approved in the European Union as a treatment for multiple myeloma.

U.S. drugmaker Celgene (CELG.O: Quote, Profile, Research) said on Monday its product Thalomid had been granted full marketing authorisation by the European Commission.

Thalomid is already cleared for multiple myeloma in the United States and the European green light had been expected after the medicine won a positive recommendation from the European Medicines Agency in January.

Aart Brouwer, president of Celgene International, said the company was now working with national regulatory authorities to determine pricing, reimbursement and distribution plans, and aimed to get the medicine to patients as soon as possible.

The International Myeloma Foundation said that despite the drug's controversial history, thalidomide had powerful anti-cancer properties, making it one of the most widely prescribed treatments for the condition in the United States.

Multiple myeloma is the second most commonly diagnosed blood cancer, affecting around 750,000 people worldwide.

Victims of thalidomide, who were born with defects ranging from malformed limbs to no arms or legs after their mothers took the drug while pregnant 50 years ago, have accepted its reintroduction but are urging extreme caution over its use.

Under the drug's new licence rules, it can only be prescribed through a special pregnancy prevention programme and must carry clear warnings that it causes birth defects.

Earlier this month, thalidomide victims launched a new 4 billion euro ($6.35 billion) campaign for compensation, aimed at the German government and the drug's original maker, privately owned German group Grunenthal [nL02865873].

(Reporting by Ben Hirschler; Editing by Quentin Bryar)

 
 

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