Drugs

FDA Rejects Cosmo’s Methylene Blue NDA

FDA has issued a complete response letter (CRL) for Cosmo Pharmaceuticals’ NDA for Methylene Blue MMX, intended as a visualization aid to increase detection of colon lesions. The company says the CRL is consistent with preliminary feedback it announced 5/9 that FDA had identified unspecified deficiencies that preclude continuation of discussion of labeling and post-marketing requirements/commitments. “The CRL states that FDA has determined it cannot approve the NDA in its present form and provides recommendations needed for resubmission,” Cosmo says.

FDA did not raise any safety or manufacturing concerns, Cosmo says. The CRL said that although a Phase 3 trial outcome translated as statistically significant, it was not sufficiently robust and thus the agency recommended that the company confirm effectiveness with a second Phase 3 trial.

“This decision fails to consider the benefit-risk of Methylene Blue MMX and the high unmet need,” says Cosmo CEO Alessandro Della Chá. “We believe the concerns raised by FDA are fully addressable, thus we will work to have a meeting with FDA as quickly as possible.”

Cosmo says that Methylene Blue MMX is a novel application of methylene blue, a coloring agent that is used to stain the mucosa to discover pre-cancerous lesions and polyps in the colon. The objective, it says, is to deliver methylene blue along the length of the entire colon via MMX technology, enabling endoscopists to better detect pre-cancerous and cancerous lesions and polyps throughout the entire colon.

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