Amgen (AMGN) and AstraZeneca (AZN) are approaching a potential catalyst event on October 19, when the FDA will rule on Tezspire for treating chronic rhinosinusitis with nasal polyps (CRSwNP). If approved, Tezspire will expand into a second high-value indication, building on its established use in severe asthma.
A complex inflammatory disorder, CRSwNP, is characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps that can severely impact the quality of life. Polyps block nasal passages and can cause breathing difficulties, impaired sense of smell, nasal discharge, facial pain, and sleep disturbances.
A recurrent condition, CRSwNP, often requires repeat courses of systemic corticosteroids, sometimes even repeat surgeries. Biologics like Sanofi/Regeneron’s Dupixent, GSK’s Nucala (with generic name mepolizumab), and Genentech/Novartis’s Xolair (omalizumab) are FDA approved to treat CRSwNP.
Tezspire’s Potential In CRSwNP
In a phase 3 trial called “Waypoint” Tezspire demonstrated potential in targeting inflammation at the epithelium to provide lasting relief for patients with CRSwNP. Tezspire showed rapid and sustainable reduction in nasal congestion, polyp size and nearly eliminated the need for surgery by 98%, while reducing the need for systemic corticosteroid treatment by 88% vs. placebo.
Also, Tezspire is already approved for severe asthma in the U.S., Europe, Japan, and over 50 other countries. In the U.S, and Europe, it is approved as a pre-filled, single-use pen and auto-injector for self-administration.
Tezspire is also the first biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. This means Tezspire can be prescribed regardless of a patient’s asthma type or biomarker levels making it potentially suitable for a broader range of patient population than other biologic asthma treatments.
If this biomarker-agnostic advantage extends to CRSwNP, Tezspire could challenge the dominance of Dupixent, which is most effective in patients with elevated type 2 biomarkers such as eosinophils or immunoglobulin E (IgE).
Tezspire’s efficacy data in CRSwNP compares slightly more favorably with Dupixent’s. In the “Waypoint” trial, Tezspire showed a placebo-adjusted improvement of nearly 2.07 points on the Nasal Polyp Score (NPS) on a scale of 0–8, and nearly 1.03 points on the Nasal Congestion Score (NCS) on a scale of 0–3. By comparison, Dupixent’s 52-week placebo-adjusted improvements were 1.8 points on NPS and 0.9 points on NCS. However, it should be noted that this does not establish the superiority of Tezspire, as cross-trial comparisons should be interpreted cautiously because of differences in clinical trial designs and other factors.
But, Tezspire does offer a slightly more convenient dosing schedule, requiring one subcutaneous injection per month, compared to Dupixent’s every-other-week regimen.
The CRSwNP market is widely projected to reach around $6 billion by 2034. Dupixent’s global net sales rose 22% year-over-year to $14.15 billion in 2024, though this number spans multiple indications beyond CRSwNP. Despite intense competition and Dupixent’s first-mover advantage, Tezspire’s strong trial data suggests that it can capture a meaningful share of the growing CRSwNP market.
On September 18th, Tezspire was also recommended for European approval for treating CRSwNP, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Why FDA Approval for Tezspire in CRSwNP Looks Promising:
- Demonstrated efficacy: Reduced the need for surgery in 98% of trial participants vs. placebo.
- Steroid-sparing effect: Reduced systemic corticosteroid use by 88% vs. placebo, demonstrating a significant benefit given the side effects of long-term steroid use.
- Established safety: Consistent with its approved use in severe asthma with no new safety signals.
- Regulatory Tailwinds: Tezspire has already received a positive opinion from the CHMP for use in CRSwNP in Europe.
- Lower-risk pathway: Tezspire is an already-approved drug, now seeking approval for an additional indication – This is typically a lower-risk pathway compared to getting approval for a new drug.
Bottom Line
With robust Phase 3 data, established global use in severe asthma and regulatory traction in Europe, FDA approval for Tezspire in October looks highly probable. Approval would not only expand treatment options for CRSwNP patients but also provide incremental upside in a multibillion-dollar market for Amgen and AstraZeneca.
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