Onglyza and Cimzia recommended by CHMP
pharmafile | July 2, 2009 | News story | Research and Development, Sales and Marketing | AZ, BMS, EMEA, Europe, Ongylza
Bristol-Myers Squibb andAstraZeneca's type II diabetes treatment Onglyza is among the brands to have received positive opinions from the Committee for Medicinal Products for Human Use this week.
Others include UCB's Cimzia (certolizumab pegol) for rheumatoid arthritis, a drug in the highly competitive anti-TNF class.
A year ago Cimzia failed to gain European approval for Crohn's disease for a second time because regulators said it lacked sufficient evidence to back up its safety profile.
Meanwhile Onglyza can be used in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
It and other DPP-4 inhibitors such as MSD's Januvia (sitagliptin) and Novartis' Galvus (vildagliptin) have fewer side-effects than treatments such as GSK's Avandia (rosiglitazone).
Last month BMS and AstraZeneca launched a national patient survey on the effects of hypoglycaemia ahead of the expected launch of Onglyza.
The Committee for Medicinal Products for Human Use (CHMP) also gave a thumbs-up to Boehringer Ingelheim's Mirapexin/Sifrol (pramipexole) in its new, once-daily prolonged-release formulation.
The dopamine agonist is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa.
The immediate release formulation of the brand is the only one currently registered, and has to be taken three times per day. Last year sales of the drug were up 21% to 752 million euros.
TiGenix's ChondroCelect has also received a positive opinion, the first advanced therapy medicinal product to do so.
It was green-lit following a draft opinion prepared by the CHMP's new Committee for Advanced Therapies.
ChondroCelect consists of chondrocytes (cartilage-forming cells) expanded in vitro, which are used to repair cartilage defects of the end of the thighbone in the knee.
The cells are taken from healthy cartilage from the patient, grown outside the body, and then re-implanted during surgery.
CHMP has also recommended granting marketing authorisation to a host of generics, for which a reference medicine is already authorised in the EU.
They include Teva Pharma's generic of Hycamtin, called Topotecan Teva (topotecan hydrochloride), intended for the treatment of ovary carcinoma, small cell lung cancer and carcinoma of the cervix.
A host of variants of Plavix, for the prevention of atherothrombotic events, have also been approved.
All contain clopidogrel and include Tad Pharma's Clopidogrel TAD and Zopya from Norpharm Regulatory Services.
Related stories:
BMS and AZ launch diabetes patient survey
June 19, 2009
Plavix to face six generic competitors in Europe
June 17, 2009
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