FDA Approves GSK’s Antibody for Chronic Disease Management

August 06, 2021 - FDA recently approved GSK’s Nucala, a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

The new indication for Nucala is an add-on maintenance treatment for CRSwNP in patients 18 years of age and older with inadequate response to nasal corticosteroids. 

Nucala is the first anti-IL-5 biologic approved for adult patients with CRSwNP in the US.

“More than 5 million people in the US suffer with chronic rhinosinusitis with nasal polyps and today’s approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease,” Hal Barron, chief executive scientific officer of GSK, said in the announcement. 

“GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients,” Barron continued. 

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FDA based its approval on data from the pivotal SYNAPSE study, which explored the effect of Nucala versus placebo in over 400 patients with CRSwNP.

In the study, Nucala achieved significant improvement in reducing the size of nasal polyps and nasal obstruction. Specifically, patients experienced a 57 percent reduction in patients who had surgery in the group treated with Nucala versus placebo.

CRSwNP accounts for two to four percent of the US population and affects over five million people. So far, researchers have studied Nucala in over 4,000 patients across 41 clinical trials. 

Previously, FDA approved the antibody for use in three other eosinophilic driven diseases, including for patients with severe eosinophilic asthma aged six years and older. 

Notably, Nucala was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic approved for patients aged 12 years and older with hypereosinophilic syndrome (HES).

FDA Approves Johnson & Johnson’s Pulmonary Arterial Hypertension Therapy

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FDA recently approved Johnson & Johnson’s Uptravi injection for intravenous (IV) use to treat adult patients with pulmonary arterial hypertension (PAH) who are unable to take oral therapy. 

Uptravi IV will allow patients to avoid short-term treatment interruptions and stay on Uptravi therapy. FDA first approved Uptravi tablets in 2015 to delay disease progression and reduce the risk of hospitalization for PAH. 

“Today marks an important day for patients who rely on UPTRAVI, as this new intravenous formulation meets a current unmet need for these patients,” Neil Davie, PhD, global therapeutic area head of pulmonary hypertension at Janssen, said in the announcement. 

“As part of our commitment to investing in research and understanding the science around the potential of UPTRAVI, we’re inspired by this approval and are proud to be paving the way to advance treatment options and care for patients with PAH,” Davie continued. 

FDA based its approvals on a multi-center Phase 3 study that assessed the safety, tolerability, and pharmacokinetics of temporarily switching between Uptravi tablets and Uptravi IV.

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In the study, researchers found that the switch between Uptravi tablets and Uptravi IV was well-tolerated with no unexpected safety findings. 

Kelly Chin, MD, Uptravi IV study senior author, associate professor of internal medicine, and director of the pulmonary hypertension program at the University of Texas Medical Center, explained that bridging short-term temporary interruptions of Uptravi tablets with Uptravi IV may maintain the treatment effect and avoid the need to change therapy for patients with PAH.

FDA Approves Label Expansion of BOTOX for Upper Limb Spasticity 

FDA recently approved a label expansion of AbbVie’s BOTOX to include eight new muscles for the treatment of upper limb spasticity in adults. 

BOTOX is now approved to treat additional muscles of the elbow and forearm, as well as intrinsic hand and thumb muscles. The label includes the use of ultrasound as a muscle localization technique in adult spasticity.

"This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX® in upper limb spasticity treatment. BOTOX® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients,” Mitchell F. Brin, MD, senior vice president and chief scientific officer of BOTOX & Neurotoxins at AbbVie, said in the announcement. 

Generally, spasticity in adults is caused by stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Spasticity can hinder a patient’s ability to perform everyday tasks and interfere with normal muscle movement and function.

BOTOX can significantly reduce muscle stiffness and treat spasticity in patients two years of age and older. 

The expanded BOTOX dosing guidance allows physicians to treat patients based on clinical assessment of spasticity and anatomy, all while staying within the BOTOX maximum dose of 400 Units in a 3-month period in adults.

Kimberly Heckert, MD, director of spasticity management fellowship at Thomas Jefferson University, explained that the label expansion offers physicians and their patients living with spasticity another vital tool as part of a comprehensive treatment plan for spasticity management.