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One less hurdle for Shire and Takeda tie-up after potential blockbuster drug wins FDA approval

Julia Bradshaw
Shire is a specialist in rare diseases

Shire’s $5.9bn (£4.6bn) purchase of rival rare disease specialist Dyax two years ago has paid off after US authorities approved the most valuable drug in the company’s pipeline.

The move will also come as a relief to Japanese pharmaceuticals giant Takeda, which is in the process of acquiring Shire for some £46bn and for whom approval of this potential blockbuster drug was deemed an important step towards sealing the deal.

The American Food and Drug Administration (FDA) gave the go-ahead to Takhzyro last night. It is a treatment for hereditary angioedema (HAE), a genetic illness that causes random attacks of severe swelling in parts of the body and can be life-threatening. It occurs in one in 10,000 to one in 50,000 people and is classified as a rare disease.

Takhzyro, which is injected once every two weeks, proved hugely successful in clinical trials, reducing monthly attacks in patients by up to 87pc, while 77pc suffered no attacks at all.

Jack Scannell, a European pharmaceuticals research analyst at UBS, said: “We struggle to recall a drug for a rare and serious disease that posted as impressive phase three data as Takhzyro.”

Shire’s acquisition of Dyax two years ago was a defensive move because the smaller biotech’s pipeline, and Takhzyro in particular, rivalled many parts of Shire’s portfolio.

Shire has two existing treatments for HAE. Cinryze is preventative, while Firazyr relieves symptoms after patients have suffered an attack. Takhzyro is more convenient for patients as it is administered less frequently and it is also more effective. 

Anthony Castaldo, president of the US Hereditary Angioedema Association, said: “HAE attacks are painful, debilitating, and potentially life threatening. Takhzyro provides the HAE community with a new option."

The medication could also help to offset any decline in sales of Firazyr as it loses its patent exclusivity next year. It will also go head to head with a similar, already marketed HAE drug called Haegarda, that was developed by US pharmaceutical company CSL Behring.

Shire has not revealed the price tag for Takhzyro, but it will not come cheap.

Shire's charismatic Danish boss Dr Flemming Ornskov

According to UBS, some HAE patients consume more than $1m worth of medications each year. The bank expects sales of Takhzyro, Cinryze, and Firazyr will total $322m, $421m, and $454m respectively next year.

FDA approval is also good news for Dyax shareholders, who are now due for a windfall. Under the terms of the acquisition, Dyax shareholders will get $4 in cash per Dyax share as a result of the regulatory milestone being reached.

Shares in Shire rose by more than 2pc to 4,516p by midday.