The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications.

In an interview with PharmaShots, Ted Omachi the Global Development Leader for Xolair and Senior Medical Director of Product Development Immunology shares details and highlights of Xolair (omalizumab) PFS for self-administration.

Shots:

• A decision on approval is anticipated by Q1 2021. If approved, Xolair PFS would become available for select patients or administration by their caregivers. If approved, Xolair PFS would provide increased flexibility for patients during the COVID-19 pandemic, particularly for high-risk such as patients with moderate to severe allergic asthma
• Genentech to explore the full potential of Xolair across a range of respiratory diseases, including nasal polyps and food allergies
• In the US, Xolair is the only biologic designed to target and block immunoglobulin E (IgE) for the treatment of patients living with moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU). Xolair is currently FDA-approved for administration by a healthcare provider in a healthcare setting

If approved, a self-administration option for Xolair could reduce in-person visits to a healthcare setting for patients and their caregivers, while allowing patients to continue receiving the care and treatment they need.

Tuba: How do you think this approval (self-administration) is going to help patients?

Ted: If a self-administration option for Xolair is approved by the FDA, it would offer more flexibility for appropriate patients. We recognize that even under normal circumstances, there is a significant burden to patients and the healthcare system by having a universal requirement for administering Xolair in the healthcare setting. During the COVID-19 pandemic, where some of these patients might be at high-risk for severe disease, there’s an even more urgent need to allow Xolair injections at home for appropriate patients.

Tuba: A quick highlight of clinical data submitted for the sBLA submission of Xolair to the US FDA?

Ted: Independent clinical studies involving patients with allergic asthma and chronic idiopathic urticaria (CIU) on Xolair treatment suggest that Xolair may be self-administered with proper training and monitoring, for appropriate patients as determined by a healthcare provider. The sBLA includes a summary of these studies as well as additional materials such as the safety data, the rationale for self-administration, human factors studies examining the ability of patients and caregivers to self-administer, and a review of factors that HCPs might use in determining what patients are appropriate for self-administration

Tuba: Also would like to know if data of PFS is better or at par vs traditional RoA (routes of administration)?

Ted: The Xolair prefilled syringe (PFS) formulation was approved by the FDA in 2018 for administration by a healthcare provider in a healthcare setting. For some healthcare providers, this offers a more convenient option relative to the lyophilized powder that requires reconstitution.

Tuba:  Xolair is a widely approved drug in multiple indications and this recent approval is only for CIU & Allergic Asthma, so shall we expect more of similar news at approval?

Ted: If approved, the Xolair self-administration option would cover all U.S. indications. In the U.S., Xolair is FDA-approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

Tuba: FDA check, EU check (with partner Novartis), what next? What are the other geographies on primary focus?

Ted: Besides the EU, Xolair self-administration is also approved in Australia, Taiwan and Argentina. We're committed to exploring the self-administration option in countries around the world where patients may benefit from this additional administration option.

We're committed to exploring the self-administration option in countries around the world where patients may benefit from this additional administration option.

Tuba: Anything unique about this PFS approval, i.e. any unmet needs which Roche addressed with this PFS?

Ted: Given the COVID-19 pandemic, there is an urgent need to provide self-administration of Xolair to patients, particularly those who are considered high-risk for severe illness. If approved, a self-administration option for Xolair could reduce in-person visits to a healthcare setting for patients and their caregivers, while allowing patients to continue receiving the care and treatment they need.

Tuba: Is Roche planning to evaluate Xolair in other indications?

Ted: In December 2019, the FDA accepted the company's sBLA for Xolair for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. Nasal polyps is a chronic condition that causes a range of symptoms impacting patients lives including loss of sense of smell and nasal congestion. A decision on approval is expected later this year.

In 2018, the FDA granted Breakthrough Therapy Designation to Xolair as a potential treatment for food allergies, and we’re excited to partner with NIH to study Xolair in a Phase III clinical trial for this use. As many as 15 million Americans have food allergies – including approximately 6 million children  and the incidence is increasing. We are hopeful about the potential to address this area of the significant need for patients.

Tuba: What kind of pricing difference shall be expected vs. the previously approved Xolair?

Ted: It is premature to discuss pricing at this time.

Tuba: As the product got its initial approval in 2003, can you discuss the journey of the product so far?

Ted: Almost two decades ago, Xolair was approved by the FDA as the first monoclonal antibody treatment for people 12 years and older with persistent allergic asthma. Since then, we have been committed to exploring the full potential of Xolair with a comprehensive research and development program across a range of debilitating allergic conditions.

In 2014, Xolair became the first FDA-approved medicine for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

A few years later, the FDA approved Xolair as the first biologic for use in children age 6 and up with allergic asthma.

In 2018, the FDA granted Breakthrough Therapy Designation to Xolair as a potential treatment for food allergies, and today, we’re excited to be partnering with the NIH on the Phase III OUtMATCH study exploring Xolair in food allergies.

Last year, the FDA accepted our sBLA for Xolair for the treatment of adults with nasal polyps and we look forward to hearing from the FDA on approval later this year.

Today, Xolair continues to be the only approved biologic designed to target and block immunoglobulin E (IgE) for these conditions. Since its initial approval in 2003, more than 460,000 patients in the U.S. have been treated with Xolair and we are thrilled this medicine has helped so many people living with allergic conditions."

Image Source: Keck Medicine of USC

About Ted Omachi:

Ted Omachi is a Medical Director in the Product Development Immunology group at Genentech, focusing on late-stage development in respiratory and allergic diseases. He joined Genentech in 2013, starting in the Medical Affairs group before transitioning to Product Development in 2015. At Genentech, he has served as Clinical Science Team Leader, Medical Monitor and Medical Team Leader for P-II, P-III, and P-IV programs in AD, nasal polyposis, chronic urticaria, and asthma. This work has involved overall clinical development planning, obtaining written and in-person regulatory feedback, study protocol writing, study execution, statistical analysis plan development, KOL interaction, interpretation of trial results, aligning with business partners, posthoc analyses, publication, and regulatory submissions