Drug news

EU CHMP recommends approval of Spectrila (asparaginase) for acute lymphoblastic leukaemia- Medac

Read time: 1 mins

Last updated:22nd Nov 2015

Published:22nd Nov 2015

Source: Pharmawand

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Spectrila (asparaginase), from Medac, for the treatment of acute lymphoblastic leukaemia. It is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adult patients.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Related news and insights

Drug news

CHMP positive recommendation for Tofidence (tocilizumab biosimilar)

Biogen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Tofidence (tocilizumab), a biosimilar monoclonal antibody referencing Rocactemra

1 mins

Drug news

New data show Rinvoq (upadacitinib) demonstrated superiority versus Dupixent (dupilumab) across primary and all secondary endpoints in an open-label head-to-head atopic dermatitis study

AbbVie announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase IIIb/IV study that evaluated the efficacy and safety of upadacitinib (Rinvoq, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (Dupixent, per its labeled dose) in adults and adolescents (greater than 12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable

2 min

Drug news

FDA approves Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections

Utility Therapeutics received approval from the FDA for Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus

1 min

See all news