CHMP thumbs up for label extensions in Europe
Mar. 27, 2020 10:19 AM ET|About: Takeda Pharmaceutical ... (TAK)|By: Douglas W. House, SA News Editor
The European Medicines Agency's advisory group CHMP has adopted positive opinions recommending label extensions for the following drugs:
Takeda's (TAK +2.3%) Adcetris (brentuximab vedotin), combined with cyclophosphamide, doxorubicin and prednisone, for previously untreated patients with systemic anaplastic large cell lymphoma.
Novartis' (NVS -2.0%) Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Johnson & Johnson's (JNJ -4.1%) Intelence (etravirine), combined with a boosted protease inhibitor and other antiretrovirals, for the treatment of HIV-1 infection in patients as young as two years old (previous limit was six years old).
Swedish Orphan Biovitrum AB's (OTCPK:BIOVF) Kineret (anakinra) for the treatment of familial Mediterranean fever (inherited disorder characterized by recurrent episodes of painful inflammation in the abdomen, chest or joints), combined with colchicine, if appropriate.
Pharming Group N.V.'s (OTCPK:PHGUF
PHGUF1.02 -0.05 -4.67%
Pharming Group N.V.
Pharming Group N.V., a specialty pharmaceutical company, develops and manufactures biopharmaceutical products in the United States, Europe, and internationally.
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) Ruconest (conestat alfa) for the treatment of acute angioedema attacks in patients as young as two years old (previous limit was adolescents).
Final decisions from the European Commission should be announced within 60 days.
Source: Seekingalpha.com