Roche blindsided by off-label Avastin fallout in India

Roche ($RHHBY), maker of pricey wet age-related macular degeneration (AMD) drug Lucentis, has long railed against countries' moves to use its cancer drug Avastin off-label for the same condition, arguing that there isn't any real proof that the med can safely treat the blinding eye disease. Now the company has new ammo to bolster its argument, as two states in India suspended sales of Avastin after it caused vision problems in patients.

India's Gujarat and Telangana states put a temporary hold on sales of Avastin, citing reports of 15 patients who experienced pain and swelling in their eyes after taking the med, Reuters reports. A top drug controller in western Gujarat told distributors to recall one batch of the drug given to patients following the reports.

And once southern Telangana caught wind of the news, the government ordered a freeze on all batches of Avastin sold in the state, drug control official Suredranath Sai told the news outlet. "We are stopping other batches also till the dust settles. We will release only if declared standard and safe for use," Sai said.

Roche's India unit is standing by Avastin, saying that it "does not promote the use of Avastin or any of its drugs in an indication for which they are not approved," the company told FiercePharma in an email. But "patient safety is always Roche's primary concern, and as such we are taking the events in India very seriously," the company said, adding that it "will co-operate fully with any investigations undertaken by the authorities."

The recent turn of events, while alarming for patients, deals some cards in Roche's favor as it lobbies against off-label Avastin use. The company has faced a rough road trying to prevent the drug from being used to treat AMD, especially in Europe, where the French and Italian governments have already greenlighted the med as an alternative to Roche and Novartis' ($NVS) more expensive eye drug Lucentis.

Especially in France, the economic benefits of subbing Avastin for Lucentis are compelling, lawmakers there have argued. Lucentis costs 30 times more than Avastin in the country, and switching to off-label Avastin for AMD could save the country about €200 million ($273 million) a year.

Still, Roche is working hard to dispel these notions. The company has not conducted any clinical trials to test Avastin for treating the eye disease, a company spokeswoman told Politico last September. And Lucentis was specifically developed for use in the eye.

Some industry groups are also backing up Roche's arguments. In September, a European industry organization filed a formal complaint with the European Commission, arguing that French regulators' decision to OK Avastin as a therapy for AMD runs afoul of the EU approval process for meds and "compromises their standard of quality, safety and efficacy and could put patients' health at risk," the European Federation of Pharmaceutical Industries and Associations said. Drugs should only be prescribed off-label in situations where there is "concrete medical need," and only after risks and benefits have been assessed, the trade group said.

- read the Reuters story

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