News &amp; Updates

New drug applications approved by US FDA as of 01-15 November 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (01-15 November 2021)

Fenfluramine helps minimize day-to-day seizure burden in Dravet syndrome

Treatment with fenfluramine in patients with Dravet syndrome (DS) appears to produce a marked reduction in day-to-day seizure burden and provide prolonged periods of convulsive seizure-free days, as shown in a study.

Fenfluramine helps minimize day-to-day seizure burden in Dravet syndrome

Allergy testing during pregnancy could prevent unnecessary antibiotic exposure

16 Nov 2021 by

Women who have a documented history of penicillin allergy should undergo allergy tests during pregnancy to avoid exposure to potentially less effective broad-spectrum antibiotics, according to a small study presented at ACAAI 2021.

Allergy testing during pregnancy could prevent unnecessary antibiotic exposure

SURTAVI: TAVR matches SAVR through 5 years in intermediate-risk AS patients

16 Nov 2021 by

The noninferiority finding between transcatheter vs surgical aortic valve replacement (TAVR vs SAVR) in intermediate-risk patients with severe aortic stenosis (AS) holds up through 5 years, according to long-term data of the SURTAVI trial presented at TCT 2021, providing reassurance that the less invasive procedure performs just as good in the elderly population.

SURTAVI: TAVR matches SAVR through 5 years in intermediate-risk AS patients

Tenofovir alafenamide safe to use in breastfeeding mothers with CHB

16 Nov 2021 by

The first human pharmacokinetic study of tenofovir alafenamide (TAF; commercially sold as Vemlidy) monotherapy in breastfeeding women with chronic hepatitis B (CHB) has found low concentrations of TAF and tenofovir in the breastmilk, with negligible exposure to infants.

Tenofovir alafenamide safe to use in breastfeeding mothers with CHB

16 Nov 2021

Aspirin shows no therapeutic potential in ARDS

In the treatment of patients with acute respiratory distress syndrome (ARDS), the use of aspirin improves neither oxygenation index nor other physiological outcomes, according to the results of a phase II study.

Aspirin shows no therapeutic potential in ARDS

Nasal spray eases signs, symptoms of dry eye disease

15 Nov 2021 by

The varenicline-containing nasal spray OC-01 appears beneficial in the treatment of dry eye disease, producing improvements in natural tear film production and patient-reported symptoms with a tolerable safety profile, as shown in the phase III trial ONSET-2.

Nasal spray eases signs, symptoms of dry eye disease

MONALEESA-2: Compelling survival data with ribociclib a ‘step forward’ in HR+/HER2- ABC

Adding ribociclib (KISQALI, Novartis) to letrozole yields significant and consistent overall survival (OS) benefit compared with letrozole alone in the first-line setting for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC), according to the final OS analysis of the MONALEESA-2 trial presented at ESMO 2021.

MONALEESA-2: Compelling survival data with ribociclib a ‘step forward’ in HR+/HER2- ABC

Belimumab benefit sustained regardless of lupus nephritis status

15 Nov 2021 by

The recombinant human IgG-1λ monoclonal antibody belimumab improved renal outcomes in patients with relapsed and newly diagnosed* active lupus nephritis (LN), according to subgroup analysis results of the BLISS-LN** trial presented at ASN 2021.

Belimumab benefit sustained regardless of lupus nephritis status