Eisai has decided to discontinue development of an extended-release version of proton pump inhibitor Aciphex/Pariet.
In February, the Japanese company received a complete response letter from the US Food and Drug Administration for he long-acting version of Aciphex (rabeprazole). Eisai adds that after "full consideration of the discussion with the FDA regarding the CRL, it was determined that an additional study would be required to support approval".
Upon further review, Eisai says it has decided to discontinue the global development of the product. The firm added that it remains committed to continue marketing Aciphex delayed-release tablets and is conducting a paediatric clinical programme for the drug with Johnson & Johnson.
Eisai's growth has been dependent on Aciphex and Aricept (donepezil) but its business will now focus on oncology, liver diseases and epilepsy. Earlier this week, the Tokyo-headquartered group outlined its progress in the latter therapeutic area at a conference in Rome.