Eli Lilly won FDA approval for its long-lasting injectable version of Zyprexa, the blockbuster antipsychotic. Dubbed Zyprexa Relprevv, the injection sustains delivery for up to four weeks, the company said, basing its application for approval on a 2,054-patient study. The drug got FDA's nod after Lilly developed a risk-management plan. And if all goes well, Relprevv will help counteract the risk of sales lost to generic versions of the regular Zyprexa.
It's a big deal for Lilly, as the Wall Street Journal Health Blog points out, because although the regular Zyprexa goes off patent in 2011, a key patent on the extended-release form doesn't expire until 2018. If Lilly can sell enough doctors and patients on the long-acting form, it could mitigate the damage from generic competition for regular Zyprexa. BMO Capital Markets analysts predicted that annual sales of the Relprevv form could hit $400 million by 2014 or 2015. That's not the multibillions brought in by Zyprexa Sr. But it's not chump change, either.
Selling points that Lilly reps will be hammering home: Long-acting therapy can help prevent relapse, a boon for patients and their families. Lilly research showed that patients using the Relprevv form won't need to supplement their therapy with oral meds, so no pills to remember. Plus, by prescribing Zyprexa Relprevv, psychiatrists will know which patients have been taking their meds (presumably they'll collect a fee for injection, too).
"There is a growing recognition among psychiatrists... that non-adherence to medication is an even greater barrier to care for patients with schizophrenia than was previously understood," Dr. John Hayes, Lilly research VP, said in a statement, "and that long-acting treatments can... [help] patients maintain a stable treatment regimen." We'll have to wait and see just how many psychiatrists recognize those benefits enough to prescribe the new drug. Stay tuned.