Insights+: The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry.

The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021.

Additionally, last year in 2020, the US FDA has approved 105 novel products. PharmaShots has compiled a list of a total of 4 new drugs approved by the US FDA in Jan 2021

Bayer and Merck’s Verquvo (vericiguat) Received the US FDA’s Approval to Treat Chronic Heart Failure

Published:Jan 21, 2021| Tags: Bayer, Merck, Verquvo (vericiguat), Receives, US, FDA, Approval ,Treat, Chronic Heart Failure

• The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
• The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
• Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

ViiV’s Cabenuva (cabotegravir and rilpivirine) Received the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Published:Jan 22, 2021| Tags: ViiV, Cabenuva (cabotegravir and rilpivirine), Receives, US, FDA, Approval, First, Only, Complete, Long-Acting Regimen, HIV treatment

• The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
• Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
• The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

ViiV’s Vocabria (cabotegravir, tablet formulation) Received the US FDA’s Approval for the Treatment of HIV-1 infection

Published:Jan 22, 2021| Tags: ViiV, Vocabria (cabotegravir, tablet formulation), Receives, US, FDA, Approval, Treatment, HIV-1 infection

• The US FDA approved Vocabria (30mg, tablet formulation) in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation
• Additionally, changes to the Edurant (rilpivirine) tablet label were revised to reflect the oral lead-in recommendations for use with Vocabria
• The oral therapy is for the patients who will miss planned injection dosing with Cebenuva

Aurinia’s Lupkynis (voclosporin) Received US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Published:Jan 25, 2021| Tags: Aurinia, Lupkynis (voclosporin), Receives, US, FDS, Approval, Treat Adult, Patients, Active Lupus Nephritis

• The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
• The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
• Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US

Related Post: The US FDA New Drug Approvals in December 2020