MS Drugs From Biogen, Merck KGaA Get CHMP Backing for Use During Pregnancy, Breastfeeding

By Colin Kellaher

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the removal of pregnancy contraindications for approved interferon beta treatments for women with relapsing multiple sclerosis, drug makers Biogen Inc. (BIIB) and Merck KGaA (MRK.XE) said Monday.

The companies said the committee issued a positive opinion to update the product label of Biogen's Plegridy and Avonex and Merck's Rebif to include that women with relapsing multiple sclerosis can continue treatment during pregnancy if clinically needed and while breastfeeding.

Merck and Biogen said the CHMP opinion is based on data that indicated no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or exposure during the first trimester of pregnancy, and that levels excreted in breast milk are negligible.

The European Commission generally follows the CHMP's recommendations.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 23, 2019 12:48 ET (16:48 GMT)

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