Shire mAb receives US FDA approval, holding blockbuster expectations

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Yarygin)
(Image: Getty/Yarygin)

Related tags Shire Takeda Monoclonal antibody

Shire’s Takhzyro has been granted approval by the FDA for the treatment of hereditary angioedema.

The treatment has been pegged as a future blockbuster, with Clarivate Analytics ranking it 9th of its 12 drugs to watch in 2018​ and noting that it expects annual sales of the therapy to be approximately $1.15bn (€1bn) by 2022.

The monoclonal antibody (mAb) proved effective in treating patients with hereditary angioedema (HAE), with patients receiving the drug experiencing an 87% reduction in the number of monthly attacks associated with the condition, in Phase III trials​.

HAE is a rare genetic disorder that results in the swelling of various parts of the body, such as the face, feet and hands.

The US Food and Drug Administration (FDA) approved the treatment on a priority review, speeding the treatment to approval, as the only mAb therapy designed to prevent the enzyme kalligrein from being overexpressed in patients with the genetic disorder.

Takhzyro (lanadelumab-flyo) is self-administered via an injection and patients need to be dosed every two weeks, though Shire stated that a dose every four weeks is also effective and can be considered after six months of treatment.

A boost to Takeda

While the FDA’s decision could be expected after the previously mentioned trial results, the quick approval will still be a means of explaining the expense of Takeda’s acquisition​ of the rare disease specialist.

At the time of the deal being struck, Takeda had pointed to Shire’s ability to bolster its pipeline as a reason for instigating the deal, with the former’s CEO, Christophe Weber, suggesting the latter held a “highly complementary product portfolio and pipeline”​.

Weber can now point to Takhzyro as an example of the kind of product within Shire’s pipeline that prompted such a statement.

The mAb is still awaiting a regulatory decision from the European Medicines Agency, with a priority review underway​ and expected to be completed by the end of the summer.

Related topics Markets & Regulations Pipelines

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