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A decade behind schedule, Shire finally gets an FDA OK for long-acting ADHD drug

Flemming Ornskov, CEO, Shire

It took a decade longer than Shire had originally bargained on, but the biotech has finally landed FDA approval of its long-acting ADHD drug SHP465.

The drug — to be sold as Mydayis — uses the same active ingredient as generic Adderall XR but extends the mainstay drug’s effective reach from 12 hours to 16, making it a one pill per day treatment.

Payers have become particularly skillful at setting up hurdles for generic makeovers, but Shire ran new trials last year to come up with the safety and efficacy data that the agency originally demanded after it was submitted in 2006.

Since then, Shire has undergone a sea change, refocusing on drugs for rare diseases. But it still pays many of the bills with its aging ADHD franchise, and the company has projected that this new long-acting drug could be worth $500 million a year. Analysts, though, have been more conservative, pegging potential peak sales under $300 million, according to consensus figures from Reuters.

Andrew Cutler, an investigator in the Mydayis clinical trials said: “Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings — often across home life, school or work, and in social settings. Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options. It’s rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD.”


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