The latest set of opinions from the European Medicines Agency includes recommendations for Pfizer's leukaemia drug Bosulif and ThromboGenics/Novartis' eye drug Jetrea.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to give conditional approval for Bosulif (bosutinib) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML). The drug is now likely to get the green light for patients previously treated with one or more other tyrosine kinase inhibitors, ie Novartis' Gleevec (imatinib) and Tasigna (nilotinib) or Bristol-Myers Squibb's Sprycel (dasatinib).
Pfizer notes that the recommendation is based on data from a Phase I/II study of bosutinib in more than 500 patients with Ph+ CML with separate cohorts for chronic, accelerated and blast phase disease previously treated with one or more prior TKIs. The drug was approved in the USA in September.
The CHMP has also recommended marketing approval for Jetrea (ocriplasmin), developed by Belgium's ThromboGenics and licensed outside the USA, for the treatment of adults with vitreomacular traction.
The drug is the first non-surgical treatment option for VMT, a condition which can cause decreased vision and the distortion of images. Sufferers currently have to have a vitrectomy, where the vitreous humour is removed surgically and which requires the patient to be in a 'head-down' position for seven-14 days and has a recovery period of four to six weeks.
Jetrea is a recombinant human protein derived from the yeast Pichia pastoris which has enzymatic activity against proteins in the interface between the vitreous humour and the retina. The treatment was approved in the USA in October.
Santhera stock sinks as Raxone is turned down
However, the CHMP has issued a negative opinion on another eye drug, namely Santhera Pharmaceuticals' Raxone (idebenone) for the treatment of Leber's hereditary optic neuropathy, which causes progressive vision loss.
The committee was concerned that in patients with LHON whose symptoms started in the previous five years, taking Raxone for six months did not lead to any significant improvement in vision compared with placebo (patients taking Raxone were able to distinguish three more letters on the letter chart).
Switzerland-based Santhera saw its share price sink nearly 22% to 3.75 Swiss francs. The company has requested a re-examination of the decision.
Other highlights of the meeting saw the CHMP recommend the green light for Novartis' cryopyrin-associated periodic syndromes drug Ilaris (canakinumab) as a treatment for frequent acute gouty arthritis. It also backed expanded approvals for AstraZeneca/Bristol-Myers Squibb's diabetes drugs Onglyza (saxagliptin) and Komboglyze (saxagliptin/metformin) and AbbVie's blockbuster Humira (adalimumab).
The CHMP also issued positive recommendations on new generics of Boehringer Ingelheim's hypertension combo Micardis HCT (telmisartan/hydrochlorothiazide) from Actavis and Krka and the latter's copy of Lundbeck's Alzheimer's disease drug Ebixa (memantine).