MS Drugs From Biogen, Merck KGaA Get CHMP Backing for Use During Pregnancy, Breastfeeding
September 23 2019 - 1:03PM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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