Mydayis is expected to launch in the third quarter of 2017 after win...
Shire has forecast annual sales of $500m by 2020 for its newly-approved ADHD drug.
Mydayis is expected to launch in the third quarter of 2017 after winning regulatory approval from the Food and Drug Administration this week.
It will join Shire’s current collection of ADHD drugs which collectively helped earn the company close to $2.4bn in sales in 2016.
Share prices for the pharma group have since risen by over 2% on the FTSE 100 stock exchange.
The approval of Mydayis is based on 16 successful clinical studies on both adults and adolescents, with the treatment significantly improving symptoms for the disorder that affects between 5-7% of children and young people worldwide as well as just over 3% of adults.
This news has been a long time coming for Shire after it first filed for regulatory approval back in 2006.
“Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD. It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD,” said Flemming Ornskov, M.D., MPH, CEO of Shire.
“With this approval, we hope to help patients who need a once-daily treatment option. Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose.”