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AstraZeneca's (AZN) Lupus Drug Saphnelo Gets Europe Nod
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AstraZeneca (AZN - Free Report) announced that the European Commission has granted approval to its biologic drug, Saphnelo (anifrolumab) to treat moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE), the most common form of lupus. The approval was expected as in December last year, the Committee for Medicinal Products for Human Use of the European Medicines Agency had given a positive opinion recommending approval of the drug.
SLE is a complex autoimmune condition in which the immune system mistakenly attacks healthy cells and tissues. It is marked by inflammation that can affect joints, skin and multiple organs which can cause long-term damage.
Saphnelo’s approval was based on data from two TULIP phase III studies and the MUSE phase II study. In clinical studies, treatment with Saphnelo led to a reduction in overall disease activity across organ systems compared to placebo. Patients treated with Saphnelo also experienced a sustained reduction in the use of oral corticosteroid (OCS) compared to placebo. Reducing the use of OCS is important in the treatment of SLE as it can reduce organ damage.
So far this year, AstraZeneca’s shares have gained 4.5% against a decrease of 3.5% for the industry.
Image Source: Zacks Investment Research
Saphnelo is the first biologic to be approved to treat SLE in Europe with the label not restricted for use in patients with a high degree of disease activity. Approximately 250,000 people in Europe are suffering from the disease. The approval of Saphnelo thus opens up a significant sales opportunity for AstraZeneca.
The drug is already approved in the United States, Canada and Japan while regulatory reviews are ongoing in additional countries. AstraZeneca plans to begin phase III studies to evaluate Saphnelo for lupus nephritis, cutaneous lupus erythematosus and myositis.
Another company developing an antibody medicine to treat SLE is Horizon Therapeutics .
Horizon Therapeutics is evaluating the novel investigational monoclonal antibody, HZN-7734, in a phase II study for moderate to severely active SLE. The composite primary endpoint of Horizon Therapeutics’ phase II study is to determine the change in British Isles lupus assessment group-based combined lupus assessment, a composite measure of overall SLE disease activity.
Some better-ranked large stocks are GlaxoSmithKline (GSK - Free Report) .and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both with a Zacks Rank of 2 (Buy).
Glaxo’s stock has risen 29.9% in the past year. Estimates for Glaxo’s 2022 earnings have gone up from $3.25 to $3.30 over the past 60 days.
Glaxo’s earnings performance has been rather strong with the company beating earnings expectations in three of the last four quarters while meeting estimates in one. Glaxo has a four-quarter earnings surprise of 20.52%, on average.
Vertex Pharmaceuticals’ stock has risen 12.4% in the past year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
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AstraZeneca's (AZN) Lupus Drug Saphnelo Gets Europe Nod
AstraZeneca (AZN - Free Report) announced that the European Commission has granted approval to its biologic drug, Saphnelo (anifrolumab) to treat moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE), the most common form of lupus. The approval was expected as in December last year, the Committee for Medicinal Products for Human Use of the European Medicines Agency had given a positive opinion recommending approval of the drug.
SLE is a complex autoimmune condition in which the immune system mistakenly attacks healthy cells and tissues. It is marked by inflammation that can affect joints, skin and multiple organs which can cause long-term damage.
Saphnelo’s approval was based on data from two TULIP phase III studies and the MUSE phase II study. In clinical studies, treatment with Saphnelo led to a reduction in overall disease activity across organ systems compared to placebo. Patients treated with Saphnelo also experienced a sustained reduction in the use of oral corticosteroid (OCS) compared to placebo. Reducing the use of OCS is important in the treatment of SLE as it can reduce organ damage.
So far this year, AstraZeneca’s shares have gained 4.5% against a decrease of 3.5% for the industry.
Image Source: Zacks Investment Research
Saphnelo is the first biologic to be approved to treat SLE in Europe with the label not restricted for use in patients with a high degree of disease activity. Approximately 250,000 people in Europe are suffering from the disease. The approval of Saphnelo thus opens up a significant sales opportunity for AstraZeneca.
The drug is already approved in the United States, Canada and Japan while regulatory reviews are ongoing in additional countries. AstraZeneca plans to begin phase III studies to evaluate Saphnelo for lupus nephritis, cutaneous lupus erythematosus and myositis.
Another company developing an antibody medicine to treat SLE is Horizon Therapeutics .
Horizon Therapeutics is evaluating the novel investigational monoclonal antibody, HZN-7734, in a phase II study for moderate to severely active SLE. The composite primary endpoint of Horizon Therapeutics’ phase II study is to determine the change in British Isles lupus assessment group-based combined lupus assessment, a composite measure of overall SLE disease activity.
Zacks Rank and Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked large stocks are GlaxoSmithKline (GSK - Free Report) .and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both with a Zacks Rank of 2 (Buy).
Glaxo’s stock has risen 29.9% in the past year. Estimates for Glaxo’s 2022 earnings have gone up from $3.25 to $3.30 over the past 60 days.
Glaxo’s earnings performance has been rather strong with the company beating earnings expectations in three of the last four quarters while meeting estimates in one. Glaxo has a four-quarter earnings surprise of 20.52%, on average.
Vertex Pharmaceuticals’ stock has risen 12.4% in the past year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.