* FDA issues complete response letter for cariprazine
* Move set to delay launch of antipsychotic drug in U.S.
* Richter shares fall 2.8 percent
BUDAPEST, Nov 21 U.S. health regulators have
declined to approve a new antipsychotic drug from Forest
Laboratories and Richter, citing the need for
more information, including likely additional clinical trial
The Food and Drug Administration (FDA) delivered its verdict
on cariprazine for schizophrenia and bipolar disorder in a
so-called "complete response letter," the type of letter issued
by the agency to convey that it cannot approve a drug
application in its current form.
Cariprazine was discovered by Hungarian drugmaker Richter
and licensed to Forest in the United States and Canada.
Industry analysts have forecast North American sales of the
drug of $250 million in 2017, according to consensus forecasts
compiled by Thomson Reuters Pharma.
In its letter the FDA acknowledged that cariprazine
demonstrated effectiveness but the two companies said on
Thursday it appeared regulators wanted more tests on the optimal
dose of the treatment to avoid potential side effects.
"This is likely to cause a delay ... (but) we cannot tell
how much; we will be able to tell after consultations with the
FDA," said Richter spokeswoman Zsuzsa Beke.
The companies said that the FDA had indicated that its
request for more information included the need for additional
clinical trial data. But Beke said it was possible this might
not turn out to be necessary.
"Whether we need more clinical tests, we can also tell that
after the consultations - it is possible that the existing data
will be sufficient," she said.
Richter's shares were down 2.8 percent by 1040 GMT.