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Alexion (ALXN) to Pause Enrollment in COVID-19 Study on Ultomiris
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Alexion Pharmaceuticals, Inc. announced that it will pause further enrollment in the global phase III study of Ultomiris (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation.
This decision was based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. A pre-planned interim analysis of the primary endpoint – survival at day 29 – once 122 patients completed the 29-day primary evaluation period was the basis of the recommendation. No secondary endpoints were analyzed as part of the interim analysis.
The committee recommended pausing additional enrollment, as the interim analysis showed a lack of efficacy when Ultomiris was added to best supportive care compared to best supportive care alone. The study will continue for patients already enrolled, including completion of all study visits and planned Ultomiris dosing, according to the study protocol.
Consequently, Alexion will conduct further analysis of trial data to determine the next step.
We note that Ultomiris, a first and only long-acting C5 complement inhibitor, is approved in the United States, the European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also approved in the United States and Japan for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients.
Meanwhile, the TACTIC-R platform study, led by the Cambridge University Hospitals NHS Foundation Trust, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. The study includes an Ultomiris cohort. This independent study is ongoing.
Given the alarming levels of the COVID-19 spread and severity, some approved drugs are being tested or repurposed to see their effectiveness in treating infected patients.
Earlier, Novartis (NVS - Free Report) and partner Incyte (INCY - Free Report) too announced that the phase III RUXCOVID study evaluating their drug, Jakafi, on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care).
Alexion’s shares have rallied 38.7% in the past year compared with the industry’s growth of 8.9%.
The stock saw a massive surge following an acquisition deal with the U.K.-based pharmaceutical company, AstraZeneca plc (AZN - Free Report) , whereby the latter will acquire Alexion for $39 billion.
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Alexion (ALXN) to Pause Enrollment in COVID-19 Study on Ultomiris
Alexion Pharmaceuticals, Inc. announced that it will pause further enrollment in the global phase III study of Ultomiris (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation.
This decision was based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. A pre-planned interim analysis of the primary endpoint – survival at day 29 – once 122 patients completed the 29-day primary evaluation period was the basis of the recommendation. No secondary endpoints were analyzed as part of the interim analysis.
The committee recommended pausing additional enrollment, as the interim analysis showed a lack of efficacy when Ultomiris was added to best supportive care compared to best supportive care alone. The study will continue for patients already enrolled, including completion of all study visits and planned Ultomiris dosing, according to the study protocol.
Consequently, Alexion will conduct further analysis of trial data to determine the next step.
We note that Ultomiris, a first and only long-acting C5 complement inhibitor, is approved in the United States, the European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also approved in the United States and Japan for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients.
Meanwhile, the TACTIC-R platform study, led by the Cambridge University Hospitals NHS Foundation Trust, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. The study includes an Ultomiris cohort. This independent study is ongoing.
Given the alarming levels of the COVID-19 spread and severity, some approved drugs are being tested or repurposed to see their effectiveness in treating infected patients.
Earlier, Novartis (NVS - Free Report) and partner Incyte (INCY - Free Report) too announced that the phase III RUXCOVID study evaluating their drug, Jakafi, on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care).
Alexion’s shares have rallied 38.7% in the past year compared with the industry’s growth of 8.9%.
The stock saw a massive surge following an acquisition deal with the U.K.-based pharmaceutical company, AstraZeneca plc (AZN - Free Report) , whereby the latter will acquire Alexion for $39 billion.
Alexion currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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