Future Medicine India – Drug Approvals Drug Approvals Archives | Future Medicine India

Drug Approvals

Ozanimod to treat adult patients with active MS

Bristol Myers Squibb announced that the European Commission (EC) has approved ozanimod (Zeposia) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease.

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Lonafarnib gets speedy review to treat progeria

EigerBio Pharmaceuticals Inc announced that the US FDA accepted the New Drug Application (NDA) for accelerated review of lonafarnib (Zokinvy) for the treatment of progeria and progeroid laminopathies.

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Atezolizumab as first-line monotherapy for mNSCLC

Atezolizumab (Tecentriq) has been granted approval by the US FDA as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained = 50% of tumour cells [TC = 50%] or PD-L1 stained tumour-infiltrating [IC] covering = 10% of the tumour area [IC = 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

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Pomalidomide for Kaposi sarcoma

Pomalidomide (Pomalyst) has been granted approval by the US FDA for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.

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Brentuximab ADC to treat sALCL in China

Takeda China announced that brentuximab vedotin (Adcetris) has been officially approved by China’s National Medical Products Administration (NMPA) for use in adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma.

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Glycopyrronium/formoterol aerosphere for COPD in China

AstraZeneca announced that its glycopyrronium/formoterol fumarate (Bevespi Aerosphere) has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

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Priority review to sutimlimab for treating hemolysis

The US FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD).

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