Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Always Active

Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.

No cookies to display.

Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.

No cookies to display.

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.

No cookies to display.

Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.

No cookies to display.

Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.

No cookies to display.

Skip to content Skip to footer

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

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]