EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars

The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug.

The advanced therapy CHMP recommended is Germany-based Co Don Ag’s Spherox (spheroids of human autologous matrix-associated chondrocytes), which is intended to treat adults who have a type of symptomatic articular cartilage defects in the knee.

The four other new medicines were:

• Dompé farmaceutici’s Oxervate (cenegermin), which has an orphan designation, for the treatment of moderate to severe neurotrophic keratitis.
• Gedeon Richter’sReagila (cariprazine), which is intended to treat schizophrenia and was approved in the US in September 2015.
• Leo Pharma’s Kyntheum (brodalumab) for the treatment of moderate to severe plaque psoriasis. Valeant Pharmaceuticals won approval for this treatment in the US in February.
• Chiesi Farmaceutici’s Trimbow (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium), which is intended to treat moderate to severe chronic obstructive pulmonary disease (COPD).

The four biosimilars recommended by CHMP include: Insulin lispro Sanofi (insulin lispro) for the treatment of diabetes mellitus, and three from Celltrion with rituximab as their active substance: Blitzima and Tuxella, for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis; and Ritemvia, for the treatment of non-Hodgkin's lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis.

CHMP also recommended six extensions to therapeutic indications and one generic drug to treat HIV, known by its brand name as Atripla (efavirenz/emtricitabine/tenofovir disoproxil).

Negative Opinions

In addition to the positive recommendations, CHMP also adopted three negative opinions for: Helsinn Birex Pharmaceuticals’Adlumiz (anamorelin hydrochloride), XBiotech Germany’s Human IgG1 monoclonal antibody specific for human interleukin-1 alpha and Masipro (masitinib). Masipro was intended to be used to treat systemic mastocytosis.

Antibiotics

CHMP also has recommended changes to the prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by gram-positive bacteria.

Meeting highlights