Takeda swings and misses with Ninlaro in AL amyloidosis, calls off phase 3 trial

fiercepharma | June 06, 2019

With its once-biggest seller Velcade bracing for generic competition, Takeda has big plans for its oral multiple myeloma drug Ninlaro. But now, the med has suffered two setbacks in the span of a few months. After Ninlaro hit a snag at the FDA in an expanded use back in February, the company this week canned a phase 3 trial in another rare disease. Ninlaro had been in phase 3 testing for patients with systemic light-chain amyloidosis, but an analysis showed the med didn't meet a primary endpoint. Investigators were testing a combo of Ninlaro and dexamethasone in patients who'd relapsed or failed to respond to another treatment. Compared with a doctor’s choice of standard chemotherapy, Ninlaro didn’t improve overall hematologic response, so Takeda called the trial off. In patients with the disease, certain plasma cells produce abnormal immunoglobulin light-chain fragments. Patients develop amyloid deposits in organs and tissues, particularly the kidneys, heart, liver and nerves, Takeda said. That, in turn, can lead to organ failure and death.

Spotlight

Forty-four U.S. states have filed a lawsuit against 20 drug companies including Teva Pharmaceuticals USA Inc. They're accused of concocting a sweeping scheme to inflate drug prices and stifle competition for more than 100 generic drugs. The drugs treated conditions including diabetes, high cholesterol, high blood pressure, cancer, epilepsy and more.

Spotlight

Forty-four U.S. states have filed a lawsuit against 20 drug companies including Teva Pharmaceuticals USA Inc. They're accused of concocting a sweeping scheme to inflate drug prices and stifle competition for more than 100 generic drugs. The drugs treated conditions including diabetes, high cholesterol, high blood pressure, cancer, epilepsy and more.

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