Eli Lilly and Co. won approval from U.S. regulators for a long-acting, injectable form of its bestselling antipsychotic
Zyprexa, the company announced Monday morning.
Zyprexa Relprevv, when injected into a patient’s muscles,
lasts up to four weeks. The U.S. Food and Drug Adminstration OK’d the long-acting version to treat schizophrenia.
The drug could bring some much-needed profit to Lilly. The Indianapolis-based drugmaker will lose most of the $4.7
billion a year Zyprexa now generates in revenue when cheaper generic versions of the drug hit the market two years from now.
But the long-acting version of Zyprexa has patents that could run until 2018. Analysts have been
predicting no more than modest revenue from the new version, since the FDA had previously declined to
approve the drug over concerns about its side effects.
But it could be significant if Lilly can duplicate the success
competitor New Jersey-based Johnson & Johnson has had with its injectable schizophrenia drug Risperdal Consta. The drug
has achieved sales of $1.3 billion a year after many patients who were taking Risperdal pills switched
over to the longer-acting version.
Long-acting medicines for schizophrenics are beneficial
because many patients don’t remember to take a pill each day and caregivers can struggle to administer the medicine
on a daily basis.
"There is a growing recognition among psychiatrists in the United States that non-adherence
to medication is an even greater barrier to care for patients with schizophrenia than was previously understood, and that
long-acting treatments can play a beneficial role in helping patients maintain a stable treatment regimen," said
Dr. John Hayes, vice president of Lilly Research Laboratories, in a prepared statement.
The FDA initially said
it could not approve long-acting Zyprexa because of concerns about it causing excessive sleepiness in some patients. But Lilly
worked with the FDA to develop a mandatory patient care program, which restricts distribution of Zyprexa Realprevv to medical
professionals or patients enrolled in the program.

















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