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
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
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
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
The post The US FDA New Drug Approvals in January 2021 first appeared on PharmaShots.