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Takeda's ixazomib moves closer to US approval

Wins priority review from the FDA

Takeda's new multiple myeloma therapy ixazomib has been awarded a priority review by the FDA, setting it on course for possible US approval in early 2016.

The US regulator granted the expedited review to ixazomib (MLN9708), the first investigational orally-active proteasome inhibitor, for the treatment of patients with relapsed and/or refractory multiple myeloma, having previously given it 'breakthrough' status in this indication.

If approved it could provide patients with an alternative to injectable proteasome inhibitors such as Takeda's own Velcade (bortezomib) and Amgen and Onyx' Kyprolis (carfilzomib).

The FDA's decision comes after ixazomib was also given accelerated review status in Europe, and gives Takeda's drug a longer lead over its nearest rival - Amgen/Onyx' orally-active oprozomib - which is in mid-stage development but has had some issues with gastrointestinal toxicity at some doses.

Takeda has high hopes for ixazomib, billing it as the company's second 'global launch' after ulcerative colitis therapy Entyvio (vedolizumab) - in other words a product that it will launch not just in major markets but more widely around the world.

The company believes an oral agent will open up a new maintenance therapy indication in myeloma, particularly as it has a good efficacy and safety profile based on phase III trial results, as well as a convenient, weekly dosing regimen.

Meanwhile, studies are ongoing to try to expand the use of the drug into patients with earlier-stage myeloma and as a first-line therapy, which could allow sales to reach around $1.2bn by 2020 despite increasing competition in the myeloma sector, according to Evaluate Pharma predictions.

"Our ixazomib program is designed to evaluate whether sustained therapy with an oral proteasome inhibitor improves the outcomes of patients living with multiple myeloma," commented Melody Brown, Takeda's vice president of regulatory affairs.

"There is a significant unmet medical need in multiple myeloma and we look forward to working with the regulatory bodies to bring ixazomib to patients."

Ixazomib will likely see competition from the outset from drugs such as Johnson & Johnson's anti-CD38 antibody daratumumab and Bristol-Myers Squibb and AbbVie's CS1-targetting  elotuzumab, which were both granted priority review just days ago, as well as Novartis' HDAC inhibitor Farydak (panobinostat) which has just been approved in Europe.

All told, the myeloma market in the US, UK, France, Germany, Italy, Spain, Japan and Canada is expected to expand in value from $7.3bn last year to $8.9bn in 2021, according to business intelligence firm GBI Research.

Article by
Phil Taylor

10th September 2015

From: Regulatory



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