Meg Marzella

AstraZeneca and Amgen’s tezepelumab(Tezspire), the first and only respiratory biologic without phenotype or biomarker limitations, has been approved for self-administration in the United States for the treatment of severe asthma in patients aged 12 years or older.

Announced on February 2, the pre-filled, single-use pen can now be administered at home in addition to a doctor’s office for patients ages 12 years and older, offering patients their choice of preferred administration.The approval comes following the results of the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE phase 1 and PATH-HOME phase 3 trials. During the trials, 92% of healthcare providers, patients, and caregivers were able to successfully administer the drug.

“Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label,” Ruud Dobber, Executive Vice Presidents of the BioPharmaceuticals Business Unit at AstraZeneca said in the statement. “With the approval of the pre-filled pen in the US we can now offer greater flexibility to patients and physicians with the option to administer Tezspire at home or in the clinic.”

Tezepelumabwas previously approved by the FDA in 2021 following a Priority Review based on the results from the PATHFINDER clinical trial program. In its pivotal NAVIGATOR phase 3 trial, tezepelumabdemonstrated superiority across all primary and key secondary endpoints in patients with severe asthma when added to standard therapy. Its 2023 approval is specifically for self-administration of the drug.

The tezepelumabpre-filled pen will be available as a fixeddose of 210mg that is to be administered every 4 weeks. The pre-filled pen makes it easier for patients and caregivers to self-administer the medication. Equipped with a safety guard and viewing window, the device has audible clicks at the beginningand end of injection to guide patients.

According to the statement, tezepelumabis being developed as “a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.”

Tezepelumabis indicated for the add-on maintenance treatment of severe asthmas in patients aged 12 years and older. The most common adverse reactions included pharyngitis, arthralgia, and back pain. There is currently no data on tezepelumabuse in pregnant women to test for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Thetezepelumabpre-filled pen and self-administration are also approved in the European Union and Japan, and it is currently under regulatory review in several other countries.

“Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire pre-filled pen as an option that will empower patients and healthcare providers with increased choice,” Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, said in a statement. “We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”

1. TEZPSIRE approved for self-administration in the US with a new pre-filled pen. News Release. AstraZeneca. February 2, 2023. Accessed February 3, 2023. 

https://www.astrazeneca-us.com/media/press-releases/2023/tezspire_approved_for_self_administration_in_the_us_with_a_new_pre_filled_pen.html

2. FDA approves TEZSPIRE™ (tezepelumab-ekko) in the U.S. for severe asthma. News release. Amgen. Published December 17, 2021. Accessed February 3, 2023.

https://www.amgen.com/newsroom/press-releases/2021/12/fda-approves-tezspire-tezepelumabekko-in-the-us-for-severe-asthma

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In December 2022, Mallya, a smart sensor that attaches to insulin pen injectors and turns a disposable pen into a device that connects to smartphones, was cleared by the FDA.

This device helped insulin pen users track their treatment information like dose taken, date, and time of injection. The information is then stored in the Mallya app via Bluetooth. The app is available for both Apple and Android smartphones.

Mallya has the ability to track dosing of glucagon-like peptide 1 (GLP-1) receptor agonists. According to the manufacturer Biocorp, this is the first device in the United States that is able toautomatically connect insulin and GLP-1 injector pens to an app. Mallya is compatible with most popular insulin pens.

Biocorp is currently partnering with Novo Nordisk, Sanofi, and Roche Diabetes Care to improve the current design of Mallya. This device can attach to many different disposable injection pens and track dosing for basal and bolus insulin and GLP-1 receptor agonists. It can easily transfer to new pens thanks to its easy installation and removal.

The device has a 2-year lifespan and requires charging once a month with the average use of 3 to 4 injections per day. Mallya can be charged using via USB. Additionally, the app can connect multiple Mallya devices for those who require multiple types of insulin.

Despite its FDA clearance, Mallya is not yet available and Biocorp has yet to announce and official launch date for the United States.

1. Briskin, A. FDA Clears Smart Injector Pen Device. diaTribe Learn. January 17, 2023. Accessed January 23, 2023.

Formerly known as PT027, albuterol/budesonide (Airsupra) has been approved by the FDA for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in adults with asthma.

The approval was based on results from the MANDALA and DENALI phase 3 clinical trials (NCT03769090, NCT03847896). Albuterol/budesonide significantly reduced the risk of severe exacerbations compared with albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in MANDALA. It also demonstrated a significant reduction of mean annualized total systemic corticosteroid exposure at the approved dose of 180 mcg albuterol/160 mcg budesonide. In DENALI, albuterol/budesonide significantly improved lung function compared to albuterol and budesonide individually in patients with mild to moderate asthma.

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control,” said Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center in Sacramento, California. “Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. [This approval] means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.”

Currently being developed by AstraZeneca and Avillion, albuterol/budesonide is a pressurized metered-dose inhaler, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid.

“With patients experiencing more than 10 million asthma exacerbations each year in the US and uncontrolled asthma expected to cost the US economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the US. Physicians will be able to offer their patients [albuterol/budesonide], an important new rescue treatment that reduces the risk of asthma exacerbations,” said Mene Pangalos, executive vice president of bioharmaceuticals research and development at AstraZeneca.

1. Airsupra (PT027) approved in the US for asthma. News Release. AstraZeneca. January 11, 2023. Accessed January 11, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html

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 The FDA’s decision came after positive topline results from the Phase 1/2 proof-of-concept study that tested the safety, tolerability, and immunogenicity of VAX-23 in adults aged 18 to 64 years.

The vaccine met primary safety and tolerability objectives with a safety profile similar to that of PCV20 (Prevnar 20). The company intends to move forward into a Phase 3 program after the study demonstrated VAX-24 meeting or exceeding established regulatory immunogenicity standards for all 24 serotypes at the 2.2 mcg dose.

Vaxcyte will have access to all elements of the FDA’s Fast Track program for the further development of VAX-24 and will receive guidance and support from the FDA.

“We are pleased to have received this important designation for VAX-24, which we believe underscores the public health need for broader protection from IPD, as well as the importance of innovative technology platforms in vaccine development, such as our cell-free, carrier-sparing approach,” said Jim Wassil, executive vice president and chief operating officer of Vaxcyte.

Topline safety, tolerability, and immunogenicity data from a pivotal phase 3 noninferiority study are expected in 2025.

1. Vaxcyte’s VAX-24 granted FDA Breakthrough Therapy Designation for the prevention of invasive pneumococcal disease in adults. News Release. Vaxcyte. January 5, 2023. Accessed January 10, 2023.

https://investors.vaxcyte.com/news-releases/news-release-details/vaxcytes-vax-24-granted-fda-breakthrough-therapy-designation

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