SAN DIEGO and WOODCLIFF LAKE, N.J., Oct. 23, 2010
/PRNewswire-FirstCall/ — Arena Pharmaceuticals, Inc. (Nasdaq:
ARNA) and Eisai Inc. announced that the US Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL)
regarding Arena’s New Drug Application (NDA) for lorcaserin.
Lorcaserin is intended for weight management, including weight loss
and maintenance of weight loss, in patients who are obese (Body
Mass Index, or BMI, >/= 30) or patients who are overweight (BMI
>/= 27) and have at least one weight-related co-morbid
condition.
The FDA has completed its review of the NDA and determined that
it cannot approve the application in its present form. In the CRL,
the FDA outlined the non-clinical and clinical reasons for their
decision.
The non-clinical issues identified by the FDA included
diagnostic uncertainty in the classification of mammary masses in
female rats, unresolved exposure-response relationship for
lorcaserin-emergent mammary adenocarcinoma, and unidentified mode
of action and unclear safety margin for lorcaserin-emergent brain
astrocytoma.
The CRL included the following requests related to the
non-clinical issues: provide a detailed accounting of all slides
prepared from female rats that contributed to mammary tumor
incidence data in each update to the FDA and to the final study
report; in consultation with the FDA, identify an independent
pathologist or group of pathologists to re-adjudicate all mammary
and lung tissues (neoplastic and nonneoplastic lesions) from all
female rats; demonstrate that the apparent increase in
aggressiveness of adenocarcinoma in rats administered lorcaserin is
reasonably irrelevant to human risk assessment; and provide
additional data/information regarding the distribution of
lorcaserin to the CNS in animals and human subjects that would
clarify or provide a better estimate of astrocytoma exposure
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