Two Drugs Fail in Trials - Pharmaceutical Executive

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Two Drugs Fail in Trials

Two mid- to late-stage drugs were put on hold this week as news of deaths in trials and endpoint failures came to light.

Biogen Idec’s rheumatoid arthritis/lupus collaboration with Roche was suspended on Monday due to deaths caused by serious infections in clinical studies. The drug, ocrelizumab, was studied in six trials; the main conclusion was that the “safety risks outweighed the benefits observed in these specific patient populations.”

While the companies have not released just how many fatalities stemmed from the trials they did state that a “detailed analysis” of the data is underway.

The same day, AstraZeneca announced that its Avastin competitor Recentin did not reach necessary endpoints in Phase II/III trials. The drug was given as a first line treatment to patients suffering from colon cancer, but didn’t prove to be any better than Roche’s Avastin in trials. The key differentiator is that Recentin is in pill form versus Avastin’s intravenous delivery system. AZ was banking on the drug’s ease of delivery to give it the edge over Roche.

This is the second time clinical trials involving this treatment have been stopped. According to Bloomberg, two years ago, patients taking Recentin for lung cancer had more adverse reactions to the drug versus those on chemotherapy alone.

Recentin is still being given to patients in a second trial to determine whether the treatment can be useful in treating colon cancer patients who are also receiving chemotherapy. The outcome of that trial will determine whether or not AstraZeneca submits the drug to FDA for consideration.

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