Japan's Eisai has big plans for its manufacturing facility at its European campus in Hatfield, U.K.
The company says regulators in the European Union have approved a new manufacturing line and it has begun production of its epilepsy drug, Fycompa, for the EU market. But its aspirations don't stop there. The company says it is seeking approval to sell the drug globally and will be asking regulators from other countries to give the facility their blessing.
Fycompa got EU approval in July as an adjunctive treatment for partial onset seizures, with or without secondarily generalized seizures, in patients ages 12 years and older, the company says. Its launch began earlier this month in the U.K., followed by Germany, Austria and Denmark.
Up to now, Eisai said the plant was making some of its other drugs for EMEA markets, Europe, Middle East, and Africa.
Eisai has big plans for expanding in the EU with hopes of turning its breast cancer drug Halaven into a blockbuster. But it is meeting some resistance. So far, the drug watchdog in the U.K. has refused to approve the treatment, citing side effects and cost, even though the company offered a discount of an undisclosed amount. It has approval in the U.S. for some uses. But the company also has indicated that with sales growing in Japan, it would give lots of love to its home market.
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