Regulatory Focus™ > News Articles > 2020 > 11 > FDA Approvals Roundup: Totect, Brilinta, Sesquient

Posted 11 November 2020 | By Renee Matthews 

FDA Approvals Roundup: Totect, Brilinta, Sesquient

3072 A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New indications and formulation
Totect nabs expanded indication for doxorubicin-related cardiomyopathy
Clinigen’s Totect (dexrazoxane injection) has been granted an expanded indication for reducing the incidence and severity of doxorubicin-induced cardiomyopathy in women with metastatic breast cancer receiving cumulative and maintenance doxorubicin therapy for tumor control.
The therapy has a previous approval as a cytoprotective agent for treating tissue damage, known as extravasation, caused when intravenous anthracycline chemotherapy leaks into healthy tissue surrounding the treatment site.
Totect’s efficacy in reducing the incidence and severity of cardiomyopathy in patients treated with doxorubicin was evaluated in three prospective, randomized, placebo-controlled studies. Cardiac function was assessed through resting left ventricular ejection fraction (LVEF) and clinical evaluation. Findings showed patients treated with Totect had significantly smaller LVEF decreases from baseline, compared with placebo arm participants. They also had fewer congestive heart failure events compared with controls. However, one of the studies reported a lower response rate to the study drug among patients with advanced breast cancer receiving Totect, compared with controls (48% vs. 63%, respectively).
Brilinta gets added indication for cutting stroke risk
AstraZeneca’s Brilinta (ticagrelor) has received a new indication for the reduction of stroke risk in patients with acute ischemic stroke (ACS) or high-risk transient ischemic attack (TIA).
This latest approval expands the drug’s use beyond management of cardiovascular disease. The drug has previous approvals for reducing cardiovascular death and heart attack in patients with ACS; lowering the rate of cardiovascular death, myocardial infarction, and stroke in ACS; and reducing risk for a first heart attack or stroke in high-risk patients with coronary artery disease.
Brilinta’s approval was supported by findings from the randomized, placebo-controlled, double-blinded, international Phase 3 THALES study of 11,018 patients showing. Data showed that daily aspirin plus twice-daily Brilinta significantly reduced the rate of a composite of stroke and death in the indicated population by 17%, compared with aspirin alone.
The FDA had granted the application a priority review designation.
Sesquient approves new formulation for status epilepticus in children and adults
Sedor Pharmaceuticals’ Sesquient (fosphenytoin sodium for injection) has been approved in a new, room-temperature stable formulation for treating status epilepticus in adult and pediatric patients.
The ready-to-dilute formulation means the therapy can be stored in prefilled liquid vials at the point of care, such as emergency departments or first responder units, making it easily accessible for speedy administration.
Status epilepticus is characterized by an epileptic seizure lasting longer than 5 minutes, or two or more episodes within 5 minutes. Patients can suffer irreversible brain damage or death if the seizure is not brought under control within an hour of onset.
Sesquient was originally approved for treating children and adults with generalized tonic-clonic status epilepticus, preventing and treating seizures during neurosurgery, and as a short-term substitute for oral phenytoin.


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Tags: FDA, US

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