European regulators begin Tysabri review
pharmafile | October 26, 2009 | News story | Sales and Marketing |Â Â EU, Tysabri, regÂ
European regulators have begun a risk-benefit review of Biogen Idec’s multiple sclerosis drug Tysabri, which has been linked to 23 cases of a serious viral infection.
Concerns over progressive multifocal leukoencephalopathy (PML) have already caused the product to be suspended from market in 2005 and 2006.
Tysabri (natalizumab) is indicated for patients with highly active relapsing remitting MS.
Despite safety worries, sales of the drug rose more than 130% last year to $813 million on the back of data showing that it may halt disease progression and even improve physical disability.
The review of Tysabri will be conducted by key European advisory committee the CHMP, which said it would use be checking to see whether additional measures were necessary to protect patient health.
The review was announced at the CHMP’s monthly meeting, where it also gave details of the products it would be recommending the European Medicines Agency approve.
CHMP positive opinions
The CHMP gave a range of ‘positive opinions’, which are usually followed by full regulatory approval within three month, including EUSA Pharma’s orphan drug Zenas (amifampridine).
This is designed to treat Lambert-Eaton Myasthenic Syndrome (LEMS) in adults, a rare autoimmune condition which affects the neuromuscular junction, where nerve cells meet muscle cells.
Symptoms include muscle weakness and fatigue, and more than half of sufferers also develop small cell lung cancer.
The Committee also adopted a positive opinion for Ratiopharm’s Sildenafil Ratiopharm (sildenafil), a generic of erectile dysfunction brand Viagra.
Similar opinions were given last month on Activis’ Sildenafil Actavis (sildenafil) and Teva Pharma’s Sildenafil Teva (sildenafil).
The final new drug to receive a positive opinion is CIS bio international’s Scintimun (besilesomab), a radiopharmaceutical for use in scintigraphic imaging, where it helps pinpoint inflammation or infection in peripheral bone in adults with suspected osteomyelitis.
CHMP recommends brand extensions
The CHMP also gave positive opinions to applications for the extension of indication in seven brands.
Lilly’s Adcirca (tadalafil), currently marketed as erectile dysfunction drug Cialis, is set to become a pulmonary arterial hypertension treatment.
The Medicines Company UK’s Angiox (bivalirudin) was recommended to include patients with ST-segment myocardial infarction undergoing primary percutaneous coronary intervention.
It is currently authorised for treatment of adult patients with acute coronary syndromes planned for urgent or early surgical intervention.
Eli Lilly’s Cymbalta and Boehringer Ingelheim’s Xeristar (both duloxetine) should both have their indications extended to include treatment of major depressive disorder.
Finally, the indications of three hypertension drugs – Boehringer Ingelheim’s Micardis and Bayer Schering’s Pritor and Kinzalmono (all telmisartan) – are set to be extended.
They will now include the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease or type II diabetes mellitus with documented target organ damage.
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