Takeda has been granted EU approval for its oral multiple myeloma drug Ninlaro, almost exactly a year after getting the nod in the US.
Ninlaro (ixazomib) is the first oral proteasome inhibitor to be registered in Europe and has been given a conditional approval for use in combination with Celgene's $6bn-a-year immunomodulatory drug Revlimid (lenalidomide) and dexamethasone in patients with myeloma who have been treated with at least one prior therapy.
The new drug gives patients an alternative to injectable proteasome inhibitors such as Takeda's own market-leading Velcade (bortezomib) as well as Amgen and Onyx' rival therapy Kyprolis (carfilzomib), which started rolling out in its first European markets earlier this year.
Takeda needs Ninlaro to gain market share quickly however, as Velcade loses patent protection in the US in 2017 and is projected by Datamonitor to lose $1bn in sales by 2020.
The approval of Ninlaro is based on the results of the phase III TOURMALINE-MM1 trial, which showed patients taking Takeda's drug lived longer without their disease worsening - an average of 20.6 months - compared to 14.7 months in participants taking the control regimen.
The conditional approval depends on data from the trial on overall survival, which should be available next year. Ninlaro is already available in the US, Canada, Israel, Australia and Venezuela, and has been filed in other markets including Japan. Sales of the drug in the six months between April and September 2016 were around 13 billion yen ($127m).
Takeda chief executive Christophe Weber said last month that Ninlaro is already capturing around 20% of new prescriptions in the second-line setting for new patients, adding that it is already accounting for one-third of Takeda's US growth despite a limited label. He predicted it will be the fastest-ever global launch for the company.
Ninlaro is however entering an increasingly crowded market, with other new entrants such as Kyprolis, Johnson & Johnson's (J&J) Darzalex (daratumumab) and Novartis' Farydak (panobinostat) already jostling for market share. Meanwhile, J&J and AbbVie are also developing first-in-class BTK inhibitor Imbruvica (ibrutinib) for myeloma, which could increase competition still further.
These new products are expected to help drive the global market for multiple myeloma therapies from $8.9bn in 2014 to around $22.4bn by 2023, according to market research firm GlobalData.