Takeda gains marketing authorisation for multiple myeloma pill
pharmafile | November 28, 2016 | News story | Sales and Marketing | Takeda, multiple myeloma
Takeda Pharmaceutical has announced that they have received conditional marketing authorisation for Ninlaro (ixazomib) for treatment of adult patients with multiple myeloma. The drug will be taken in capsule form, which will be used in combination with lenalidomide and dexamethasone. The drug will be the first and only oral proteasome inhibitor to treat multiple myeloma and will be used to treat patients who have receive one prior therapy.
The European Commission had previously rejected the treatment back in May of this year but reversed its decision. The conditional marketing authorisation is dependent upon Takeda providing post-approval updates upon the safety and efficacy of the drug from ongoing trials.
The approval comes on the back of a Phase 3 trial that displayed that Ninlaro, in addition to lenalidomide and dexamethasone, increased progression-free survival by approximately six months in patients with relapsed and refractory multiple myeloma.
“When developing Ninlaro, Takeda Oncology’s scientists sought to formulate an efficacious and unique oral proteasome inhibitor with a manageable safety profile. NINLARO delivers the proven efficacy of a proteasome inhibitor in a convenient once-weekly pill that can be taken at home,” said Christophe Bianchi, president, Takeda Oncology.
He continued, “Ninlaro has the potential to help European patients with relapsed multiple myeloma by removing some of the barriers that can stand in the way of optimal treatment. With NINLARO, our hope is that many patients will be able to continue therapy until disease progression. Following the European Commission’s approval, we will continue to study NINLARO in a variety of settings in the hopes that we can bring this medicine to as many of the patients who may benefit from it as possible.”
Takeda expects Ninlaro to reach sales of $3 billion to become its latest blockbuster. It requires the drug to be a success, as its own leading drug in the field, Velcade, loses patent protection next year in the US. This will reduce sales of this particular drug by as much $1 billion by 2020.
Ben Hargreaves
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