AbbVie committed to extending clinical value of its therapeutics

Key takeaways:

• AbbVie’s neuroscience areas include migraine, movement disorders, psychiatric disorders and neurodegenerative diseases.
• The company is working to expand the indications for all of its migraine products.

BOSTON — With a multitude of products spanning neuroscience and psychiatry, executives at AbbVie say they are committed to learning the full clinical value of all of the company’s products for the benefit of patients.

“As an organization, the single purpose, from science to research, is improving the outcomes for our patients,” Nikil Patel, vice president, neuroscience, U.S. medical affairs, told Healio during an interview at the American Academy of Neurology annual meeting.

AbbVie’s core neuroscience areas are migraine, movement disorders, psychiatric disorders and neurodegenerative diseases, Patel said.

Botox (onabotulinumtoxinA), Qulipta (atogepant) and Ubrelvy (ubrogepant) are AbbVie’s flagship migraine drugs, and the company continues to work toward expanding their indications.

“Migraine is a complex disease, different from patient to patient and attack to attack,” Patel said. “With the FDA approval [of Qulipta for chronic migraine], it will be the only oral calcitonin gene-related peptide receptor antagonist option for patients with both episodic and chronic migraine. All patients have an opportunity to benefit. Those with chronic migraine are most burdened. We want to make sure we have an oral preventive treatment option for these patients.”

Aubrey Adams, therapeutic area head, migraine and therapeutic neurotoxins, U.S., AbbVie, said the ELEVATE study [presented at the conference] is evaluating Qulipta in patients for whom two to four other medications have failed.

“We’re excited to bring [these] data because it matters to providers to have options for the journey,” Adams said. “ELEVATE speaks to the commitment AbbVie has to fully know the clinical value of all of our products to bring treatment options across the migraine spectrum. Wherever you are as a migraine patient, our aim is to have a treatment option.”

“AbbVie is committed to giving the patient a voice,” Patel said. “ It’s not just the headache days, it’s the impact migraine is having on their lives. We are bringing that voice of the patient to our trials.

“There’s an ambition around this migraine portfolio to have the tools to give patients a greater opportunity to achieve migraine freedom,” he continued. “That’s so important to us as a company.”

Patel also discussed AbbVie’s involvement in psychiatry treatment.

“In December we got an indication for major depressive disorder for Vraylar [cariprazine],” Patel said. “Our other indications are adult schizophrenia, bipolar 1 depression, and mixed and manic bipolar 1 disorder, so we cover bipolar to depressive disorders.”

AbbVie’s neurodegeneration efforts focus on Parkinson’s and Alzheimer’s diseases, Patel said.

Duopa (carbidopa/levodopa enteral suspension) is a surgical option approved for motor fluctuation in patients with advanced Parkinson’s, he said.

“We feel the next wave of the pipeline will be a subcutaneous option,” he said.

“Our last pillar for neuroscience is neurorehabilitation,” Patel said. “We have 12 indications for Botox and are also looking at episodic migraine. We hope to have a full indication. ”

ABBV-916 (a-beta) is an IV agent in phase 1B trials for early Alzheimer’s disease, he added.

AbbVie received a complete response letter from the FDA for ABBV-951, designed to treat motor fluctuations in adults with advanced Parkinson’s disease, requesting additional information as it relates to the device (pump). The letter did not request that AbbVie conduct additional efficacy and safety trials related to the drug.

AbbVie told Healio that it plans to resubmit the new drug application as soon as possible.

“These patients are on orals ... We’re bringing this new innovation to market as quickly as possible, as it demonstrates superiority [over orals],” Patel said.