BELLUS Health Inc. (BLUSF)

[surf1944]

Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis
Friday December 14, 8:24 am ET

ECUBLENS, Switzerland, Dec. 14 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX - News; TSX: NRM - News), announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a negative opinion recommending refusal of the marketing authorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis and concluding that another study would be needed to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company is currently reviewing all of its options in view of this opinion, including the option of requesting a re-examination of the opinion by CHMP. As provided by the European regulations, the Company may request that the CHMP consult a Scientific Advisory Group (SAG) in connection with the re-examination. The deadline for filing any such request is within fifteen days of receipt of notification of the opinion.women and the elderly, along with a study comparing it to a drug already on the market, before it can approve it for sale.

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