Drugs

2nd Complete Response on AbbVie Parkinson’s Drug

FDA has issued AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson’s disease. In the letter, the agency cited observations that were identified during an inspection of a third-party manufacturer listed in the submission, the company says, adding that the inspection at the facility did not involve ABBV-951 or any other AbbVie drug. “We are focused on working with the FDA to bring this important therapy to patients as soon as possible,” the company says.

AbbVie notes the letter does not identify any issues related to the safety, efficacy or labeling of ABBV-951, including its delivery device. It also does not request that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing, it adds.

In 3/2023, FDA issued AbbVie its first complete response letter for ABBV-951, requesting additional information about the product’s device (pump), the company said at the time, adding that there were no requests to conduct additional efficacy and safety trials related to the drug (see earlier story).

ABBV-951 is designed to provide 24-hour, continuous subcutaneous delivery of carbidopa/levodopa prodrugs. “Compared to oral CD/LD, it offers the potential for improvement in motor fluctuations in patients with advanced Parkinson's disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance,” AbbVie says.

The NDA submission is based on data from the company’s Phase 3, head-to-head, controlled clinical trial demonstrating statistically significant improvement in “on” time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa, the company says.

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