miscellaneous and sundry EU drug approvals...
EU Panel Backs Novartis' Galvus For Diabetes Treatment
LONDON -(Dow Jones)- Europe's main medical regulator Thursday backed the use
of Swiss drug-maker Novartis AG's (NVS) Galvus for type 2 diabetes treatment.
An advisory committee for the European Medicines Agency, or EMEA, issued a
positive opinion on Galvus for use with other drugs.
The EMEA's advisory committee also backed two proposed drug treatments from
Pfizer Inc. (PFE) - anti-fungal Ecalta and HIV drug Celsentri. It also backed
PharmaMar SA's Yondelis, a soft tissue sarcoma treatment.
The regulator's recommendations need to be endorsed by the European
Commission, which typically signs off on them within a few months.
The panel also backed extensions for a range of drugs, allowing drugs already
in use to be used in different treatments.
These include Novartis's Aclasta, which has been approved to treat
osteoporosis in post-menopausal women. Aclasta is already in use to treat the
bone condition known as Paget's disease.
Avastin, a cancer drug from Roche Holding AG (RHHBY), has also been cleared
for use in non-small-cell lung cancer, the agency said.
Amgen Europe BV's Aranesp and Dompe Biotec SpA's Nespo have been cleared to
treat anemia in children under 11. Amgen Europe is a unit of Amgen Inc. (AMGN).
Chiron Corp.'s Cubicin has been cleared for additional use in endocarditis.
Glustin, a pill for glycemic control marketed by Takeda Pharmaceutical Co. (
4502.TO), has also been cleared for additional uses.
GlaxoSmithKline PLC's (GSK) Telzir has been granted extensions for use as an
HIV treatment in children and adolescents older than six. |
