Janssen Pharma: Europe's CHMP Gives Positive Opinion on Approval of Darzalex Formulation
April 30 2020 - 04:21PM
Dow Jones News
By Stephen Nakrosis
The Janssen Pharmaceutical Cos. of Johnson & Johnson on
Thursday said a European Medicines Agency committee gave a positive
opinion recommending the approval of Darzalex subcutaneous
formulation for certain adult patients with myeloma.
The company said the EMA's Committee for Medicinal Products for
Human Use recommended approving the Darzalex, or daratumumab,
formulation "for the treatment of adult patients with multiple
myeloma in frontline and relapsed/refractory settings."
The company said the subcutaneous formulation reduces the amount
of time it takes for patients to receive the treatment from hours
to five minutes or less, and added "if approved, daratumumab
subcutaneous formulation will be the first monoclonal antibody
approved in Europe for subcutaneous administration for patients
with multiple myeloma."
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 30, 2020 16:06 ET (20:06 GMT)
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