Shire finally finishes a 10-year trek back to the FDA with an old ADHD drug
A long 10 years after the FDA first rejected Shire’s ADHD drug SHP465, the biotech has finally got the therapy back up in front of regulators. Shire said this morning that the FDA has acknowledged receiving their application for the therapy, which has the modest goal of extending a mainstay ADHD drug’s reach from 12 hours to 16 hours.
That extra 4 hours is enough to make SHP465 — which has the same active ingredient as the now generic Adderall XR — a once-daily pill, which is what drove the original submission back in 2006. And Shire is now setting the stage for a drug launch in the second half of this year.
The Lexington, MA-based Shire has become a substantially different kind of biopharma company since it first tried fielding SHP465, made up of mixed amphetamine salts. But it still owes a considerable amount to its ADHD franchise, which also includes Vyvanse. The drug market is also considerably changed, as payers have sharpened their knives for any generic makeovers that come their way. Insurers have become expert at finding ways to keep members on less expensive drugs, with little regard to dosing regimens.
Shire, though, has kept the faith that this drug can carve out market share, pushing through new studies that wrapped up last summer, with more evidence on safety and efficacy that had been demanded by the agency.
Their PDUFA date is slated for June 20.
“As the medical community broadens its understanding of ADHD and the ways it impacts people differently, it is important to expand the long-acting treatment options available to health care professionals to address patient needs,” said Andrew J. Cutler, MD, Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the SHP465 clinical trials.