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Roche issues counterfeit drug warning in US

Counterfeit versions of the cancer-fighting drug Avastin have been discovered in circulation in the United States, public health officials and the Swiss pharmaceutical company Roche warned
Wednesday.

“The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy,” the US Food and Drug Administration said in a statement.

Charlotte Arnold, spokeswoman for the Roche US-based unit Genentech, said that because the counterfeit lacks the active ingredient, “it’s not safe or effective for use. It should not be used. We are still analyzing what is in the product. We know that there is no biological product in it.”

In a related action, FDA said it had issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin.

The 19 medical practices purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that is also known as Montana Health Care Solutions.

The FDA asked QSP’s US distributor in Tennessee to stop using any remaining products from the supplier.

Genentech said some of the counterfeit US lots are believed to be labeled as Avastin 400 mg/16 ml and have the serial numbers B86017, B6011 and B6010.

Genentech said the suspect batches differ from the official product, which is certified by the FDA. Genuine Avastin boxes are normally marked with six digit serial numbers and have no letters, stated the company.

Avastin is among Roche’s top-selling drugs with sales of 5.3 billion francs ($5.8 billion) in 2011.

Last year, the FDA revoked the authorization of Avastin for breast cancer treatment, saying its effectiveness was not proven, but allowed it to remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer.

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Swiss-American antibody drug ‘effective at preventing Covid infection’

US biotech firm Regeneron and its Swiss partner Roche unveiled promising clinical trial results Monday indicating that an antibody treatment used to treat Covid-19 patients also helps prevent infections.

Swiss-American antibody drug 'effective at preventing Covid infection'
Photo: Fabrice COFFRINI / AFP

The results of the Phase 3 trial showed that the combination of the antibodies casirivimab and imdevimab dramatically reduced the risk of symptomatic infection among people living with Covid-19 patients, Roche said in a statement.

The trial entailed injecting 1,505 people not infected with the SARS-CoV-2 virus but living in households with people carrying the virus with the Regeneron antibody cocktail or a placebo.

READ MORE: Why are vaccination appointments still vacant in Zurich?

The trial, which was conducted in cooperation with the National Institute of Allergy and Infectious Diseases, showed that those who received the antibody cocktail saw their risk of symptomatic infection reduced by 81 percent, the companies said.

It also indicated that those treated with casirivimab and imdevimab who did experience symptomatic infection on average saw their symptoms clear within one week — far faster than the three-week average for those who received the placebo.

In a separate part of the study, 204 people who had recently tested positive for Covid-19 but showed no symptoms received either a dose of the antibody cocktail or a placebo.

Those who received the cocktail saw their risk of developing symptoms reduced by 31 percent compared to the placebo group, the companies said.

“Today’s data confirm the potential dual value of casirivimab and imdevimab to reduce household Covid-19 infections and to decrease the disease burden in those who do become infected, when given as a subcutaneous option,” Levi Garraway, Roche’s chief medical officer said in a statement.

“Although vaccinations are increasing globally, there remains a critical unmet need worldwide to prevent infections and provide immediate protection from Covid-19 between close contacts,” he said.

EXPLAINED: How Switzerland is speeding up its vaccination programme

Regeneron president and chief scientist George Yancopoulos agreed, pointing out that in the United States alone, 60,000 people are being diagnosed with Covid-19 every day.

The antibody cocktail “may help provide immediate protection to unvaccinated people who are exposed to the virus”, he said in a statement, adding that it could also potentially “provide ongoing protection for immunocompromised patients who may not respond well to vaccines”.

Regeneron said it would present the data to the US Food and Drug Administration and request it clear the Covid antibody cocktail for use as a preventative treatment.

The companies said they would share the new data with health regulators worldwide.

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