Shire’s ADHD therapy Elvanse achieves EU regulatory milestone

Shire has announced that its new attention deficit/hyperactivity disorder therapy Elvanse has taken another step towards receiving European regulatory approval.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has carried out a review of the medicine as part of a European Decentralised Procedure that will ultimately see the drug approved across a number of major EU nations, including Germany, Ireland and Spain.

Intended for children aged six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate, Elvanse has now been recommended for approval by the MHRA, based on positive data from phase III trials.

The drug is already approved in the US under the name Vyvanse and in Brazil as Venvanse, while it will be called Tyvense when it makes its Irish debut.

Angus Russell, chief executive officer at Shire, said: "We will now work closely with the pricing and reimbursement authorities in the respective countries to ensure that Elvanse is made available to patients as soon as possible."

Last month, the company announced an alliance with the Boston Children’s Hospital, focusing on the development of new therapies for rare paediatric diseases.