J&J-AbbVie’s star product suffers setback; Lilly suspends Latruvo promotion

By PharmaCompass

2019-01-24

Impressions: 141 Article

Several drugs suffered a setback recently. First, AbbVie and Johnson & Johnson’s blockbuster Imbruvica was expected to be approved for pancreatic cancer. The drug is already approved to treat six diseases, and Imbruvica has been ultra-successful since its market debut in 2013. However, it looks the approval for pancreatic cancer is unlikely to come.

Imbruvica combined with two chemo drugs failed to top the chemo duo alone in a Phase 3 study of previously untreated pancreatic cancer patients whose disease had metastasized. Placebo won out at staving off cancer progression and at lengthening patients’ lives, AbbVie and J&J said.

AbbVie and J&J aren’t the only drugmakers who have lost the battle for treating pancreatic cancer, one of the most aggressive and deadliest forms of the disease bearing five-year survival rates below 9 percent, and it’s primarily treated with chemo.

The second drug to face an uncertain future was a type 1 diabetes treatment — sotagliflozin — developed by Lexicon Pharmaceuticals and Sanofi.

An advisory panel to the US Food and Drug Administration (FDA) was divided over whether to recommend it for approval for type 1 diabetes or not. The panel voted 8-8 when asked to assess the once-daily oral medicine, sotagliflozin, as an add-on to insulin therapy.

Insulin has been used to treat diabetes for decades, but side effects include hypoglycemia (a condition in which blood sugar falls to dangerously low levels) and weight gain.

According to Pablo Lapuerta, chief medical officer at Lexicon, sotagliflozin, which was tested in two doses, could help manage and maintain glucose levels while reducing the risk of hypoglycemia.

The third drug to face disappointment was Eli Lilly’s Lartruvo. Lilly suspended Lartruvo promotion after Phase 3 failure. Lartruvo failed the study in advanced or metastatic soft tissue sarcoma, an indication for which it gained accelerated approval back in October 2016.

In a statement, Lilly said it is suspending promotion of Lartruvo and working with global regulators to determine the next steps for the drug.

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