AbbVie Provides Regulatory Update On Parkinson's Disease Drug Candidate

AbbVie Inc ABBV provided a regulatory update on its New Drug Application (NDA) for ABBV-951 Wednesday morning.

What To Know: AbbVie said it received a response from the U.S. Food and Drug Administration (FDA) on its NDA for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

The NDA is based on results from a Phase 3 clinical trial, which demonstrated statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa.

The FDA did not request additional trials related to the drug, but the agency asked for additional information about the pump device as part of its review.

"We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible," said Thomas Hudson, senior research and development vice president and chief scientific officer of AbbVie.

See Also: Roche Joins Hand With Lilly To Improve Early Diagnosis Of Alzheimer's Disease

ABBV Price Action: AbbVie has traded between $134.10 and $175.90 over a 52-week period. The stock wasn't reacting much to the news on Wednesday.

AbbVie shares were down 0.41% at $156.14 at the time of publication, according to Benzinga Pro.

Photo: courtesy of AbbVie.