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Sanofi Wins EU Nod for Subcutaneous Sarclisa in Multiple Myeloma
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Key Takeaways
Sanofi secured EC approval for subcutaneous Sarclisa across all EU-approved multiple myeloma uses.
Sarclisa becomes the first anticancer therapy delivered via an on-body injector in the EU.
Phase III IRAKLIA study data backed approval, showing SC Sarclisa matched the IV version efficacy.
Sanofi (SNY - Free Report) announced that the European Commission (EC) has approved the subcutaneous (under the skin or SC) formulation of its multiple myeloma (MM) drug, Sarclisa (isatuximab). This version, which can be administered through either an on-body injector (OBI) or a manual injection, is approved across all indications for which the drug’s intravenous (into the vein or IV) version is already approved in the region.
With this nod, Sarclisa becomes the first anticancer treatment to be administered through an OBI. It is also the first MM therapy to offer the flexibility of both SC OBI and manual injection administration in the European Union (EU).
This approval was expected after the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending the approval of the SC formulation in March. Both the EC and CHMP decisions are supported by data from the phase III IRAKLIA study, which showed that treatment with Sarclisa SC was at least as effective as the IV version.
Sanofi is also seeking approval for the SC version in the United States, where a regulatory filing supported by the IRAKLIA study is currently under FDA review. A final decision is expected next month.
The SC formulation could provide a meaningful advantage over the IV version by reducing treatment administration time. Per Sanofi, the SC version can be delivered in approximately 13 minutes compared with up to several hours for the IV infusion. The shorter administration time may improve patient convenience, reduce the burden on healthcare providers and infusion centers, and potentially support broader adoption of the therapy.
SNY’s Stock Performance
Year to date, shares of Sanofi have declined 7% against the industry’s 4.4% growth.
Image Source: Zacks Investment Research
More on Sanofi’s Sarclisa
Sarclisa is approved in the EU across four multiple myeloma indications. In combination with Bristol Myers' (BMY - Free Report) Pomalyst (pomalidomide) and dexamethasone, the drug is approved for adults with relapsed or refractory MM who have received at least two prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor. Sarclisa is also approved in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed/refractory MM (RRMM) who have received at least one prior therapy.
The SNY drug is also approved in combination with Velcade (bortezomib), Bristol Myers’ Revlimid and dexamethasone for adults with newly diagnosed MM who are ineligible for autologous stem cell transplant. This combination regimen is approved for adults with newly diagnosed MM who are eligible for autologous stem cell transplant.
Sarclisa is approved for similar indications in the United States.
Both Pomalyst and Revlimid are approved therapies in the MM space. Kyprolis is approved in combination with other drugs to treat certain RRMM patients.
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Sanofi Wins EU Nod for Subcutaneous Sarclisa in Multiple Myeloma
Key Takeaways
Sanofi (SNY - Free Report) announced that the European Commission (EC) has approved the subcutaneous (under the skin or SC) formulation of its multiple myeloma (MM) drug, Sarclisa (isatuximab). This version, which can be administered through either an on-body injector (OBI) or a manual injection, is approved across all indications for which the drug’s intravenous (into the vein or IV) version is already approved in the region.
With this nod, Sarclisa becomes the first anticancer treatment to be administered through an OBI. It is also the first MM therapy to offer the flexibility of both SC OBI and manual injection administration in the European Union (EU).
This approval was expected after the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending the approval of the SC formulation in March. Both the EC and CHMP decisions are supported by data from the phase III IRAKLIA study, which showed that treatment with Sarclisa SC was at least as effective as the IV version.
Sanofi is also seeking approval for the SC version in the United States, where a regulatory filing supported by the IRAKLIA study is currently under FDA review. A final decision is expected next month.
The SC formulation could provide a meaningful advantage over the IV version by reducing treatment administration time. Per Sanofi, the SC version can be delivered in approximately 13 minutes compared with up to several hours for the IV infusion. The shorter administration time may improve patient convenience, reduce the burden on healthcare providers and infusion centers, and potentially support broader adoption of the therapy.
SNY’s Stock Performance
Year to date, shares of Sanofi have declined 7% against the industry’s 4.4% growth.
Image Source: Zacks Investment Research
More on Sanofi’s Sarclisa
Sarclisa is approved in the EU across four multiple myeloma indications. In combination with Bristol Myers' (BMY - Free Report) Pomalyst (pomalidomide) and dexamethasone, the drug is approved for adults with relapsed or refractory MM who have received at least two prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor. Sarclisa is also approved in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed/refractory MM (RRMM) who have received at least one prior therapy.
The SNY drug is also approved in combination with Velcade (bortezomib), Bristol Myers’ Revlimid and dexamethasone for adults with newly diagnosed MM who are ineligible for autologous stem cell transplant. This combination regimen is approved for adults with newly diagnosed MM who are eligible for autologous stem cell transplant.
Sarclisa is approved for similar indications in the United States.
Both Pomalyst and Revlimid are approved therapies in the MM space. Kyprolis is approved in combination with other drugs to treat certain RRMM patients.
Sanofi Price
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SNY’s Zacks Ranks
Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.