AMG-157/MEDI-9929

Tezepelumab

Severe asthma

Tezepelumab is a potential game changer for patients with non-TH2 or TH2-low asthma whose asthma is not well-controlled with inhaled corticosteroids, the current standard of care. Greenlighted by FDA in December and marketed under the brand name Tezspire, it is a first-in-class biologic for this patient population.

About tezepelumab

  1. Amgen and AstraZeneca
  2. MAb inhibiting thymic stromal lymphopoietin (TSLP)
  3. Monthly subcutaneous (SC) injection for treatment of severe asthma
  4. 30% of patients with severe asthma have a TH2-low phenotype

Why is it a drug to watch?

Tezepelumab targets the asthma inflammatory process earlier in the pathway than other treatments. It will likely be a first-line biologic for severe TH2-low asthma and a treatment option for TH2-high asthma patients who have failed existing therapies.

  1. It has potential to treat both TH2-low asthma and TH2-high asthma.
  2. Because of its MOA, high eosinophil levels do not need to be confirmed prior to administration, eliminating the need for a blood test.
    • This could also make it attractive as a first-line option for TH2-high asthma.
  3. In the phase 3 NAVIGATOR 3 trial, tezepelumab:
    • was well-tolerated by patients with severe asthma and
    • resulted in reductions in the asthma exacerbation rate (AER), compared with placebo, of:
      70% for TH2-high asthma patients,
      41% for TH2-low asthma patients and
      39% for non-TH2 asthma patients.

Review and approval status

September 2018: 
For patients with severe asthma without an eosinophilic phenotype:

  • Breakthrough Therapy Designation: U.S. FDA

April 2021:
BLA submitted to the FDA

May 2021:
Filing submitted in Japan

July 2021:
FDA granted priority review

August 2021:
Filing submitted in the EU

December 2021:
FDA authorized use as add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma

Expected launch: 
2022: United States
2023: Europe and Japan

 Patents estimated to expire beginning in 2028

How will tezepelumab impact the market for asthma?

  1. Mainstays of symptomatic treatment are oral corticosteroids.
  2. Within this therapeutic area, the bulk of expenditure on therapies is in severe, uncontrolled asthma.
  3. Tezepelumab is:
    – a first-in-class humanized MAb and
    – the only member of the anti-TSLP class in late-phase clinical trials for asthma.
  4. Novel MOA of tezepelumab is a step forward in addressing the high level of variability within the asthma patient population.
  5. We anticipate robust uptake upon launch, given:
    – its potential efficacy for TH2-low asthma and
    – the significant unmet need in this population of asthma patients.

What gaps in treatment does tezepelumab fill?

Tezepelumab targets a subset of asthma patients who are underserved by available therapies and therefore have high unmet need, including patients with uncontrolled asthma with a non-TH2 /TH2-low phenotype who do not respond well to existing therapies. Dependence on oral corticosteroids for disease control is often not wholly effective and associated with long-term side effects. This is one of the most exciting emerging therapies for asthma treatment.

What hurdles might it need to overcome to reach blockbuster status?

Tezepelumab will face significant competition in TH2-high asthma patients, for whom it is expected to be used as later-line therapy given physician familiarity with existing biologics. With its later-to-market entry than other biologics for this patient population, payer restrictions could constrain uptake, similar to other high-priced biologics. For TH2-low asthma, there is no competition. For both phenotypes, the niche patient population with uncontrolled severe asthma could limit its overall patient share.

$1.17B
Expected sales in 2026
95%
probability of success for
tezepelumab in the United States.
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of December 15, 2021

Drug Timeline & Success Rates

– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021

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