Bristol's Kidney Transplant Drug Belatacept Finally Approved
This article was originally published in The Pink Sheet Daily
Large patient registry will help keep tabs on risk for post-transplant lymphoproliferative disorder.
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While many of the world's leading drug companies have relied on mega-mergers and diversified portfolios to drive growth over the last five years, Bristol-Myers Squibb Co. has taken a different tact, jettisoning non-core businesses, slashing overhead and jobs, and announcing a plan to focus its portfolio solely on biopharma.
FDA's "complete response" letter for kidney transplant drug does not require that Bristol-Myers Squibb do additional clinical trials, but firm must provide updates from ongoing study before approval.
Bristol-Myers Squibb is willing to tailor the patient population for its kidney transplant agent belatacept by selecting for a biomarker and limit use by recommending the less intensive treatment regimen to try and avoid the risk of post-transplant lymphoproliferative disorder that was seen in clinical trials