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THOUSAND OAKS, Calif. - The U.S. Food and Drug Administration has approved TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older, Amgen (NASDAQ:AMGN) and AstraZeneca announced Friday. Amgen, a prominent player in the biotechnology industry with a market capitalization of $161 billion, continues to demonstrate strong financial health according to InvestingPro analysis.
TEZSPIRE is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that initiates inflammatory responses.
CRSwNP affects up to approximately 320 million people worldwide and is characterized by persistent inflammation and benign polyp growths within the nasal cavity. Patients commonly experience airflow obstruction, congestion and impaired sense of smell. This approval could further boost Amgen’s already impressive revenue growth of 12.9% over the last twelve months, with total revenue reaching $34.9 billion.
The FDA approval was based on results from the WAYPOINT Phase III trial, which demonstrated that TEZSPIRE significantly reduced nasal polyp severity and nearly eliminated the need for surgery while reducing systemic corticosteroid use compared to placebo.
"By targeting thymic stromal lymphopoietin at the top of the inflammatory cascade, TEZSPIRE offers a novel option for patients who continue to endure the disruption of this disease despite available treatments," said Dr. Joseph Han, co-primary investigator of the WAYPOINT trial.
The safety profile in the trial was consistent with TEZSPIRE’s established profile in severe asthma. The most frequently reported adverse events were COVID-19, nasopharyngitis and upper respiratory tract infection.
This approval marks the second indication for TEZSPIRE, which was previously approved for severe asthma. Regulatory applications for the CRSwNP indication are currently under review in Europe, China, Japan and several other countries.
According to the press release, TEZSPIRE works on the primary source of inflammation, the airway epithelium, by blocking TSLP, which is released in response to multiple triggers associated with airway inflammation.
In other recent news, Amgen has launched AmgenNow, a direct-to-patient program offering its cholesterol medication, Repatha, at a nearly 60% discount, bringing the price down to $239 monthly. This initiative is accessible to all patients, including those uninsured or on high-deductible health plans, and even those in government programs like Medicare and Medicaid. Additionally, Amgen announced positive results from its Phase 3 VESALIUS-CV clinical trial, which showed that Repatha significantly reduced cardiovascular events in high-risk individuals without a prior history of heart attack or stroke. The study enrolled over 12,000 patients, with most on high-intensity or moderate LDL-C reducing therapy, and followed them for about 4.5 years. Following these results, Bernstein SocGen Group and Oppenheimer have both reiterated their Outperform ratings for Amgen, with price targets set at $335 and $380, respectively. Furthermore, Amgen revealed a $650 million investment to expand its manufacturing facility in Juncos, Puerto Rico, expected to create around 750 new jobs. This expansion aims to enhance drug production capabilities and incorporate advanced technologies in the operations process. These developments reflect Amgen’s ongoing efforts to strengthen its product offerings and operational capacity.
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