The European Medicine’s advisory committee has issued positive opinions on the following four therapies: Biogen Idec and Elan’s multiple sclerosis drug Tysabri; Abbott’s Humira for ankylosing spondylitis; Sanofi-Aventis’ Acomplia for weight loss; and Pfizer’s Sutent for difficult-to-treat cancers.
Tysabri for MS
Biogen Idec and Elan’s Tysabri (natalizumab) has taken a giant leap towards a re-launch in Europe, after the Committee for Human Medicinal Products recommended the drug for the treatment of patients with certain types of MS. A final seal of approval by the European Commission could see the agent could be back on the shelves as early as the summer.
The move comes hot on the heels of a similar decision in the US last month, where the Food and Drug Administration’s advisory committee also gave the thumbs up for the product’s return – although on a restricted basis.
Tysabri was taken off the market in February 2005 after it emerged that three patients taking the drug developed a rare brain disease called progressive multifocal leukoencephalopathy, leading to two deaths. It’s withdrawal came as a severe blow to both firms, which were pinning their hopes on the drug for future growth, given that it had been tipped to achieve peak sales of $2 to $3 billion by 2007.
Humira for ankylosing spondylitis
The CHMP has issued a positive opinion for Abbott Laboratories’ rheumatoid arthritis drug Humira (adalimumab) as a treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.
The recommendation was based on results of the Phase III ATLAS trial, which showed that 58% patients receiving Humira experienced at least a 20% reduction in signs and symptoms of pain and inflammation at 12 weeks.
If approved, this additional indication should give a nice boost to Humira’s sales, which are already performing well, jumping 39% to $392 million in the first quarter of this year.
Humira is currently indicated for the treatment of rheumatic and psoriatic arthritis, and is sold in around 65 countries around the world. Its potential is also being evaluated in autoimmune diseases, such as Crohn’s disease.
Acomplia for obesity
Sanofi-Aventis’ Acomplia (rimonabant) has received a nod from the CHMP for inducing weight loss in overweight patients with risk factors such as dyslipidaemia or diabetes type 2.
The decision was based on comprehensive safety and efficacy data, including results of the 6,600-patient RIO trial, which showed that the agent had a significant effect on weight and waist circumference as well as on levels of HbA1c, high-density lipoprotein cholesterol and triglycerides.
Commenting on the drug’s potential, Luc Van Gaal, Professor of Diabetology, Metabolism and Clinical Nutrition at Antwerp University Hospital in Belgium and lead investigator of the RIO Europe trial, remarked that Acomplia will “offer physicians a new approach to offering multiple cardiometabolic risk factors in patients with abdominal obesity who have other conditions such as type 2 diabetes or unhealthy lipids.” But he went on to warn that the agent should only be where there is a “real medical need,” and not for purely cosmetic reasons.
Acomplia, a first-in-class selective CB1 blocker, is widely tipped to become a future blockbuster and represents a key player in the Sanofi’s growth strategy. It is hoped that the drug will help the company to overcome generic erosion of sales of some of its key players, including the antihistamine Allegra (fexofenadine), the diabetes drug Amaryl (glimepiride), Arava (leflunomide) for arthritis and DDAVP (desmopressin).
Sutent for cancer
Pfizer’s Sutent (sunitinib malate) has been recommended for difficult-to-treat gastrointestinal stromal tumours (GIST) in patients resistant or intolerant to Novartis’ Gleevec (imatinib mesylate), and for metastatic renal cell carcinoma, or kidney cancer, after failure of interferon alfa or interleukin-2 therapy.
In May last year Pfizer released clinical data showing that Sutent extended survival to nearly 20 months in patients with GIST that had not responded to Gleevec, the first drug to be approved for this indication.
In patients with advanced renal cell carcinoma, results showed that the agent cut the size of tumours with an overall response rate of 26%-37%. In this indication, Sutent will go head-to-head with another new product, Bayer and Onyx' Nexavar (sorafenib tosylate), which was cleared by the FDA last month.
Its strong clinical backing helped Sutent to win a green light in the USA earlier this year for both of the above indications, and the firm is hoping that the drug’s approval around the globe will help it weather patent expiries on existing brands that could carve up to $14 billion off its revenues.