Drugs

Advisors Considering Data from 2 Maribavir Trials

The FDA Antimicrobial Drugs Advisory Committee meets 10/7 to consider Takeda’s maribavir to treat cytomegalovirus (CMV) infection in the post-transplant setting. An agency briefing paper distributed in advance of the meeting says Takeda submitted a Phase 2 and Phase 3 trial evaluating the efficacy of maribavir for treating resistant or refractory CMV infection or disease in solid organ and stem cell transplant recipients.

FDA medical reviewers say that both trials have significant limitations, but there is a considerable unmet need for antiviral drugs to treat CMV infection and disease which is resistant or refractory to treatment with currently available therapies.

“The charge to the committee is to advise whether data from these trials support the use of maribavir for treatment of resistant or refractory CMV infection and disease,” the document says. “If the data are not deemed adequate to support the proposed indication, FDA asks the advisory committee to provide input on what additional studies or trials may be needed.”

The reviewers say that maribavir provides some advantages over currently available therapies. It appears to have a better safety profile, they say, and is available as an oral tablet, providing ease of administration. One of the drug’s disadvantages, the document says, is its low barrier to resistance and potential cross-resistance to valganciclovir or ganciclovir.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome