The approval of viloxazine is supported by data from an extensive development programme consisting of four phase III clinical trials that studied more than 1000 paediatric patients from the age of 6 to 17 years.
In December 2020, the company announced positive results from a phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for viloxazine in adults in the second half of 2021.
Isatuximab combo to treat relapsed MM
Sanofiannounced that the European Commission (EC) approved isatuximab (Sarclisa) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy.
This marks the second EC approval of isatuximab in combination with a standard of care regimen in less than 12 months.
This EC approval closely follows the US FDA approval of isatuximab for a similar indication in March 2021.
In June 2020, Sanofi announced isatuximab received EC approval in combination with another standard of care regimen, pomalidomide and dexamethasone (pomdex), for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
This story is from the May 2021 edition of Future Medicine India.
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This story is from the May 2021 edition of Future Medicine India.
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