-- Scott Roberts
THURSDAY, June 16 (HealthDay News) -- Nulojix (belatacept) has
been approved by the U.S. Food and Drug Administration to prevent
rejection of a transplanted kidney in adults.
The immunosuppressant drug is among a class called selective
T-cell costimulation blockers. Without immune-suppressing drugs,
the immune system could recognize the transplanted organ as
foreign, leading to organ rejection, the agency said in a news
Nulojix was considered safe and effective after being evaluated
in clinical studies involving more than 1,200 patients. Common
adverse reactions recorded during the trials included anemia,
constipation, kidney infection, and swelling of the ankles, legs or
feet, the FDA said.
The new drug, designed to be injected with other
immunosuppressants, will carry a boxed warning for increased risk
of post-transplant lymphoproliferative disorder (PTLD), a form of
cancer characterized by excessive white blood cell growth after an
organ transplant. A separate label warning will note an increased
risk of other forms of cancer, as well as serious infections, the
Nulojix is marketed by Bristol-Myers Squibb, Princeton, N.J.
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