The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have brought some good news for Boehringer Ingelheim and Novartis, plus a thumbs-up for possibly the continent’s first anti-malaria medicine.
First up, the CHMP has recommended approval of Boehringer’s Trajenta (linagliptin) for type 2 diabetes as monotherapy and in combination with metformin and metformin plus sulfonylurea. The once-daily dipeptidyl peptidase-4 inhibitor was approved in the USA last month (sold as Tradjenta) and is partnered with Eli Lilly.
The European regulator has also recommended granting a conditional marketing authorisation for Novartis’ Votubia (everolimus) as a treatment for patients with subependymal giant cell astrocytoma, (benign brain tumours) associated with tuberous sclerosis who are not candidates for curative surgical resection. This means the agency is waiting for the submission of final results from a Phase III study and the long-term follow-up on the efficacy and safety in SEGA patients.
There were also thumbs-ups for Buccolam (midazolam) from ViroPharma for prolonged, acute, convulsive seizures in paediatric patients, the first CHMP recommendation for a paediatric-use marketing authorisation and for Sigma-Tau’s Eurartesim (dihydroartemisinin/piperaquine phosphate) for the treatment of uncomplicated Plasmodium falciparum malaria, also a first for the committee.
On the negative side, the committee has turned down Bronchitol (mannitol) from Pharmaxis Pharmaceuticals for cystic fibrosis, though the Australian firm is expected to request a re-examination, and Lux Bioscience’s Luveniq (voclosporin) for the treatment of chronic non-infectious uveitis.
The committee also adopted a negative opinion for the orphan medicine Glybera (alipogene tiparvovec) from Amsterdam Molecular Therapeutics. It is a gene-therapy product intended for the treatment of adults diagnosed with lipoprotein lipase deficiency demonstrating hyperchylomicronaemia or having a history of acute pancreatitis.
Other highlights of the CHMP meeting saw the reversal of a previous negative opinion on an extension of indication for Amgen’s Vectibix (panitumumab), which has now been recommended for use in combination with specific chemotherapy in patients with wild-type KRAS metastatic carcinoma of the colon or rectum. The committee also rejected generic versions of AstraZeneca’s advanced prostate cancer treatment Zoladex (goserelin) which have been marketed by Acino AG and Cell Pharm.
The CHMP concluded that the bioanalytical studies submitted could not be relied upon, because they were not conducted in accordance with good clinical practice, so therapeutic equivalence of these medicines to Zoladex, has not been demonstrated. As such, marketing authorisations on Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names should therefore be suspended in Europe until new studies are carried out.
