Roche Scientific Company (India) Ltd, the local arm of Swiss drug maker F Hoffman-La Roche, will launch a new-generation rheumatoid arthritis drug, Actemra, in India, even as it awaits approvals from US and European drug regulators.
Roche expects to start selling Actemra by April 2009, company sources said. India will be the second country to launch the drug, Japan being the first.
The Indian drug regulator Drug Controller General of India (DCGI) usually approves a new drug marketing application based on safety and efficacy data cleared by regulators in the US, EU and other developed countries. Most multinationals launch drugs in developing countries like India only after a few years of sales in the US and Europe.
The US Food and Drug Administration (FDA) has delayed its approval of Actemra mainly on concerns over the safety of the drug, production and labelling. The US FDA asked Chugai, Roche's Japanese arm, and Roche to conduct fresh animal trials to verify that the drug won’t affect pregnancy or fertility in people, Bloomberg reported yesterday.
Actemra is also linked to increased cholesterol levels, changes in liver function and problems in the digestive tract, the report said.
We have given a restricted approval for only rheumatoid arthritis and that too only at the discretion of the prescribing physician, said Surinder Singh, DCGI.
“It is a debilitating disease and we felt that we should not deprive the patient of the drug. If tomorrow we come to know there is some serious adverse reaction, even if that happens in Japan we will not hesitate to remove it from the market instantly,” he added
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Roche India sources said the common adverse events reported in clinical studies were mild and reversible and the drug is generally well tolerated. Roche said it has conducted an extensive clinical development programme on the drug, including five clinical studies enrolling more than 4,000 patients in 41 countries, including in the US.
Two weeks ago, the European Committee for Medicinal Products for Human Use had recommended the EU drug regulators approve this intravenous drug to be sold in Europe as RoActemra. The drug is likely to get EU approval in three to four months.
In Japan, Chugai has been selling Actemra since 2005 for an immune disorder and received clearance from Japanese drug regulators in April this year as a treatment for rheumatoid arthritis.
Sources said this is the second time, the US FDA has delayed its decision to approve this drug. According to reports, Chugai and Roche filed their application to the FDA in November 2007 and the regulator had sought more information on production and labelling in September, 2008.
The US regulator’s decision seeking new data could delay the launch by more than a year since Roche said it expected to submit the new information in the third quarter of next year.