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Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma
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Sanofi (SNY - Free Report) announced that the FDA has approved the label expansion for the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab).
With this nod, Sarclisa is now approved in combination with Velcade (bortezomib), Bristol Myers’ (BMY - Free Report) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant (ASCT).
The FDA’s approval is based on data from the phase III IMROZ study, which evaluated Sarclisa plus standard-of-care (SOC) VRd in NDMM patients who are not eligible for transplant. The study met its primary endpoint — treatment with the Sarclisa-VRd-combination reduced the risk of disease progression or death by 40% versus VRd in the given patient population.
Following this approval, Sarclisa is the first anti-CD38 therapy in combination with VRd for treating transplant-ineligible NDMM patients. A regulatory filing is currently under review in the EU seeking approval for the Sarclisa-VRd combination in this indication, also supported by data from the IMROZ study.
SNY Stock Performance
Sanofi’s shares have gained 15.9% year to date compared with the industry’s 23.6% growth.
Image Source: Zacks Investment Research
SNY’s Progress With Sarclisa in the MM Space
This latest FDA approval marks the first approval for Sarclisain NDMM patients and the third overall approval for the drug in the country.
Sarclisa, in combination with Bristol Myers’ Pomalyst (pomalidomide) and dexamethasone, is approved to treat adult patients with MM who have received at least two prior therapies, including Revlimid and a proteasome inhibitor. The SNY drug is also approved in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed/refractory MM (RRMM) who have received 1–3 prior lines of therapy. The drug is also approved for both of these indications in the EU.
Both Bristol Myers’ Pomalyst and Revlimid are approved in the MM space. Kyprolis is also approved in combination with other drugs to treat certain RRMM patients.
Sanofi is also evaluating Sarclisa in multiple ongoing late-stage studies in combination with other current SOC therapies to treat MM across different settings.
The approval for expanded use in NDMM patients is expected to boost sales of the drug in future quarters. The successful development in other MM indications would also help the company compete with J&J (JNJ - Free Report) , whose blockbuster anti-CD38 therapy Darzalex is approved for similar use in the MM space. The J&J drug is currently approved for a total of seven MM indications across different settings for use either as monotherapy or in combination with other drugs.
Gets Positive CHMP Nod for Dupixent in Young Children With EoE
In a separate press release, Sanofi and its partner Regeneron (REGN - Free Report) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the use of their blockbuster drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years.
A final decision is expected in a few months. If approved, the SNY/REGN drug will be the first medication approved for EoE in this age group. Dupixent is already approved in the EU to treat EoE in individuals aged 12 years and older.
This recommendation is based on data from the late-stage EoE KIDS study that showed that a significant number of patients treated with Dupixent achieved histological disease remission compared with placebo. The reported results were consistent with improvements seen in individuals aged 12 years and older.
Dupixent is a key top-line driver for Sanofi and Regeneron. During first-half 2024, Sanofi recorded €6.14 billion from Dupixent product sales, indicating 27% year-over-year growth. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are likely to be higher. Sanofi expects Dupixent to achieve about €13 billion by this year’s end and a low double-digit CAGR till 2030. The drug recently received approval in the EU for a sixth indication — chronic obstructive pulmonary disease (COPD). A regulatory filing is currently under review with the FDA seeking approval for the drug in COPD indication. A final decision is expected before this month’s end.
Regeneron and Sanofi are jointly marketing Dupixent under a global collaboration agreement. SNY records global net product sales of Dupixent, while REGN records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
Image: Bigstock
Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma
Sanofi (SNY - Free Report) announced that the FDA has approved the label expansion for the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab).
With this nod, Sarclisa is now approved in combination with Velcade (bortezomib), Bristol Myers’ (BMY - Free Report) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant (ASCT).
The FDA’s approval is based on data from the phase III IMROZ study, which evaluated Sarclisa plus standard-of-care (SOC) VRd in NDMM patients who are not eligible for transplant. The study met its primary endpoint — treatment with the Sarclisa-VRd-combination reduced the risk of disease progression or death by 40% versus VRd in the given patient population.
Following this approval, Sarclisa is the first anti-CD38 therapy in combination with VRd for treating transplant-ineligible NDMM patients. A regulatory filing is currently under review in the EU seeking approval for the Sarclisa-VRd combination in this indication, also supported by data from the IMROZ study.
SNY Stock Performance
Sanofi’s shares have gained 15.9% year to date compared with the industry’s 23.6% growth.
Image Source: Zacks Investment Research
SNY’s Progress With Sarclisa in the MM Space
This latest FDA approval marks the first approval for Sarclisain NDMM patients and the third overall approval for the drug in the country.
Sarclisa, in combination with Bristol Myers’ Pomalyst (pomalidomide) and dexamethasone, is approved to treat adult patients with MM who have received at least two prior therapies, including Revlimid and a proteasome inhibitor. The SNY drug is also approved in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed/refractory MM (RRMM) who have received 1–3 prior lines of therapy. The drug is also approved for both of these indications in the EU.
Both Bristol Myers’ Pomalyst and Revlimid are approved in the MM space. Kyprolis is also approved in combination with other drugs to treat certain RRMM patients.
Sanofi is also evaluating Sarclisa in multiple ongoing late-stage studies in combination with other current SOC therapies to treat MM across different settings.
The approval for expanded use in NDMM patients is expected to boost sales of the drug in future quarters. The successful development in other MM indications would also help the company compete with J&J (JNJ - Free Report) , whose blockbuster anti-CD38 therapy Darzalex is approved for similar use in the MM space. The J&J drug is currently approved for a total of seven MM indications across different settings for use either as monotherapy or in combination with other drugs.
Gets Positive CHMP Nod for Dupixent in Young Children With EoE
In a separate press release, Sanofi and its partner Regeneron (REGN - Free Report) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the use of their blockbuster drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years.
A final decision is expected in a few months. If approved, the SNY/REGN drug will be the first medication approved for EoE in this age group. Dupixent is already approved in the EU to treat EoE in individuals aged 12 years and older.
This recommendation is based on data from the late-stage EoE KIDS study that showed that a significant number of patients treated with Dupixent achieved histological disease remission compared with placebo. The reported results were consistent with improvements seen in individuals aged 12 years and older.
Dupixent is a key top-line driver for Sanofi and Regeneron. During first-half 2024, Sanofi recorded €6.14 billion from Dupixent product sales, indicating 27% year-over-year growth. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are likely to be higher. Sanofi expects Dupixent to achieve about €13 billion by this year’s end and a low double-digit CAGR till 2030. The drug recently received approval in the EU for a sixth indication — chronic obstructive pulmonary disease (COPD). A regulatory filing is currently under review with the FDA seeking approval for the drug in COPD indication. A final decision is expected before this month’s end.
Regeneron and Sanofi are jointly marketing Dupixent under a global collaboration agreement. SNY records global net product sales of Dupixent, while REGN records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
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SNY’s Zacks Ranks
Sanofi currently carries a Zacks Rank #3 (Hold).