FDA Approves New Sub-q Tx for Asthma – Tezspire

The FDA recently approved a new subcutaneously administered therapy, Tezspire (tezepelumab-ekko) from AstraZeneca AB and Amgen, as an add-on maintenance treatment used to improve severe asthma symptoms when used with a patient’s current asthma medicine. Tezspire is approved for adults and children aged 12 years and older with severe asthma not controlled by their current asthma medicine.

Tezspire is a monoclonal antibody and the only biologic to date to significantly reduce exacerbations across a broad spectrum of severe asthma patients. This group accounts for roughly 10% of the world’s 339 million asthma sufferers.

The cost for Tezspire subcutaneous solution (210 mg/1.91 mL) is around $3,835 per vial which is the prescribed volume for the once monthly injection.

The companies did not release distribution details. It will be interesting to see if this therapy goes into limited distribution given the somewhat large patient population and ‘relatively’ low cost. If so, it may be the first specialty therapy approved in quite some time that has not gone LD. However, both Amgen and Astra Zeneca have long histories showing their preference for LD.

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FDA approves maintenance treatment for severe asthma

Action:

FDA has approved Tezspire (tezepelumab-ekko) injection as an add-on maintenance treatment used to improve severe asthma symptoms when used with a patient’s current asthma medicine. Tezspire is approved for adults and children aged 12 years and older with severe asthma not controlled by their current asthma medicine. Tezspire is the first asthma treatment targeting thymic stromal lymphopoietin, a molecule involved in airway inflammation. Tezspire is also the first treatment for severe asthma that is not limited to a specific type of severe asthma.

Tezspire is administered once every four weeks by a health care professional through a subcutaneous (under the skin) injection.

Disease or Condition:

Asthma is a long-term inflammatory disease that causes the airways of the lungs to become swollen or inflamed and can be triggered by several factors, including allergen or irritant exposure and viral infections. An asthma attack (exacerbation) can include wheezing, cough, chest tightness, and make it hard to breathe.

Severe asthma attacks can be intense, last for long periods of time, and impact daily activities. Severe asthma symptoms usually do not get better with use of short-term treatments. Approximately 5-10 percent of Americans with asthma have severe asthma.

Effectiveness:

Safety and effectiveness of Tezspire were demonstrated in two clinical trials (NCT02054130 and NCT03347279), where participants with severe asthma received Tezspire 210 mg or placebo subcutaneously once every four weeks for 52 weeks.

Participants receiving Tezspire had significant reductions in the annualized rate of asthma attacks compared to placebo. Additionally, there were fewer asthma attacks requiring emergency room visits and/or hospitalization among participants treated with Tezspire compared to placebo. The benefits of Tezspire seen in participants weren’t limited by specific severe asthma type.

Safety Information:

Tezspire should not be used to treat short-term asthma symptoms or short-term asthma attacks. Patients should not discontinue systemic or inhaled corticosteroid treatments abruptly after starting therapy with Tezspire. Reductions in corticosteroid treatment dose, if appropriate, should be gradual and performed under the direct supervision of a health care professional. Patients with pre-existing helminth infections should be treated for the helminth infection before starting therapy with Tezspire for asthma. Patients with a serious hypersensitivity reaction to Tezspire must not take Tezspire. Live vaccines should be avoided in patients receiving Tezspire.

Designations:

Tezspire received breakthrough designation for the treatment of severe asthma.

CLICK HERE: See the prescribing information for additional information 

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