Regulatory

AstraZeneca, Amgen roll up a ‘breakthrough’ at the FDA in hot pursuit of a potential game changer in asthma

By this point, the novelty of the FDA’s breakthrough therapy designation has largely been worn away by a drumbeat of announcements for new additions to the program. But AstraZeneca and Amgen just landed one that deserves a closer look.

Bahija Jallal

Regulators have handed the big league partners VIP status for a severe asthma drug called tezepelumab. As always, BTD gives them ready access to FDA insiders who are now pledged to help push this through to a speedy conclusion. And we know now that that promise is worth something.

What makes this drug a standout is its ability to target thymic stromal lymphopoietin — TSLP – an upstream modulator of multiple inflammatory pathways like IL-4, IL-5 and IL-13.

In a Phase IIb readout, treatment-resistant patients demonstrated reductions of 61% to 71% in their annual exacerbation rate. And that has execs at both of the pharma companies stoked that this drug could be worth billions if it reaches the market.

Bahija Jallal, who runs AstraZeneca’s big subsidiary MedImmune, has called the results “unprecedented,” and Leerink’s Seamus Fernandez pegged peak potential sales at $4.5 billion. That could arrive sooner than later, he added, depending on the FDA’s willingness to let this study stand as a registrational landmark that would allow for a confirmatory Phase III to offer enough evidence worthy of approval.

Asthma, though, is not cancer. Late-stage programs in the field often run into years. And there’s no final word from the companies on their Phase III program, or whether regulators will need to see data from dose-ranging studies before they give their decision. But the developers’ chances of being put on the inside track just got better.

Both Amgen and AstraZeneca — which has been staggering through a set of fresh setbacks outside of the oncology group — could use a big OK. And while there are no guarantees that regulators will play along here, they just took an important step forward along the road to a potential blockbuster OK.


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Director, Financial Planning and Analysis
Molecular Templates Austin, TX
Manufacturing Associate – Downstream
Molecular Templates Austin, TX
Senior Statistician
Koneksa Health New York, NY

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