Swiss approval for Novartis’ Tasigna
pharmafile | August 31, 2010 | News story | Sales and Marketing | Novartis, Tasigna, Tekamlo
Novartis’ Tasigna has received its first European approval as a first-line treatment after Swiss authorities green-lighted the blood cancer drug following a fast-track review.
It can now be used in Switzerland to treat patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Health authority Swissmedic was the first to approve Tasigna on launch in 2007 as a second-line treatment after Novartis’ own Glivec (imatinib).
But a head-to-head trial between Tasigna and Glivec – Novartis’ second biggest earner, with sales of $3.94 billion last year – showed the former is more effective, resulting in lower rates of cancer progression even after only 12 months of therapy.
Tasigna’s success is important as Novartis faces competition: Bristol Myers Squibb’s Sprycel (dasatinib) recently produced data showing its response rate was superior to Glivec.
Glivec’s track record in extending lives is impressive – most patients with Ph+ CML achieve a five-year survival, something rarely seen in cancer patients – but its patent expires in 2015.
“With this approval of Tasigna as a first-line treatment, we are pleased to offer newly-diagnosed CML patients a new and even more effective option for delaying disease progression,” said Hervé Hoppenot, president of Novartis Oncology.
Despite Glivec’s effectiveness, many patients start to develop resistance to the drug, while Tasigna remains effective.
Tasigna is a selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML, and is active against a broad spectrum of Bcr-Abl mutations associated with resistance to Glivec.
The drug’s first-line approval in Switzerland follows a similar US approval in June and Novartis says a number of other regulators around the world are also currently considering the indication.
But it hasn’t been plain sailing this year for Novartis: in August its knuckles were rapped by the FDA over a US website for the brand.
At issue was a Facebook sharing widget that generated Novartis-created information – which the FDA deemed misleading – about its drug for sharing on the popular social network.
Blood pressure combination Tekamlo approved
Meanwhile the FDA has approved Novartis’ Tekamlo (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure, combining the company’s direct renin inhibitor Tekturna (aliskiren) with calcium channel blocker amlodipine (the now off-patent Istin/Norvasc from Pfizer).
It will be used as initial therapy in those likely to need multiple drugs or as replacement therapy for patients whose blood pressure is not controlled with either aliskiren or amlodipine alone.
“The treatment of high blood pressure remains a challenge for many patients requiring multiple medications to control their condition,” said David Epstein, division head of Novartis Pharmaceuticals.
Clinical trial data showed that taking the combination treatment resulted in decreases in systolic/diastolic blood pressure compared to each drug individually.
Adam Hill
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