Green light for new medicines

EMA Highlights by Gary Finnegan – Several new medicines have been approved by the EMA’s influential Committee for Medicinal Products for Human Use (CHMP), including the first non-surgical treatment for vitreomacular traction (VMT).

VMT is an eye condition which can cause severe visual disturbance. It typically occurs with age as the vitreous humour in the eye undergoes shrinkage, resulting in a pulling force on the area of the retina known as the macula.

Until now, the only available treatment has been surgery to remove the vitreous humour, often resulting in several weeks out of work and up to two weeks in the ‘head down’ posture to increase the surgery’s success rate.

Jetrea from ThromboGenics contains ocriplasmin, a recombinant human protein derived from the yeast Pichia pastoris. Ocriplasmin has enzymatic activity against proteins in the interface between the vitreous humour and the retina. By breaking down these proteins, ocriplasmin can loosen the adhesion between the vitreous humour and the macula and can therefore resolve traction at the macula.

ThromboGenics benefited from the EMA’s support for small and medium-sized enterprises, including specialist advice and reduce fees.

The CHMP also backed a new treatment from Pfizer for chronic myelogenous leukaemia (CML). Bosulif, which will come in 100 mg and 500 mg film-coated tablets, contains a protein kinase inhibitor (L01XE14) which acts by inhibiting the abnormal Bcr-Abl kinase that promotes CML.

The benefits with Bosulif are its haematological or cytogenetic response rates in patients with CML previously treated with one or more tyrosine kinase inhibitor and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Meanwhile, AbbVie Limited, Abbott’s new biopharmaceutical spin-off company which was launched at the beginning of the year, has benefited from an update to its marketing authorisation for Humira.

The CHMP said that Humira, a ground-breaking biological anti-inflammatory for conditions including rheumatoid arthritis, can be used in polyarticular juvenile idiopathic arthritis in combination with methotrexate.

The combination is approved for children and adolescents aged two to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.