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

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

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

The US FDA has approved 6 NDAs and 2 BLAs in 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 37 novel products in 2021

Additionally, last year in 2020, the US FDA has approved 121 novel products. PharmaShots has compiled a list of a total of 8 new drugs approved by the US FDA in Jun 2021

Scynexis Brexafemme (ibrexafungerp tablets) Receives the US FDA's Approval as the First Oral Non-Azole Treatment for Vaginal Yeast Infections

Published:Jun 2, 2021 | Tags: Scynexis, Brexafemme, ibrexafungerp tablets, US, FDA, Approval, Oral Non-Azole, Vaginal Yeast Infections

  • The approval is based on results from two P-III studies evaluating ibrexafungerp which demonstrates efficacy and a favorable tolerability profile in women with VVC
  • Scynexis has partnered with Amplity to support US commercial launch of Brexafemme which is expected to available in H2'21 while the therapy is also being evaluated in CANDLE study for the prevention of recurrent VVC & company plans to submit a sNDA in H1'22
  • The therapy has received both QIDP and FT designations from FDA to prevent VVC. Scynexis continues to advance its pipeline of ibrexafungerp indications to create a long-lasting antifungal franchise in both hospital and community settings

Chimerix's Tembexa (brincidofovir) Receives the US FDA's Approval for the Treatment of Smallpox

Published: Jun 4, 2021 | Tags: Chimerix, Tembexa, brincidofovir, US, FDA, Approval, Smallpox

  • The approval is based on efficacy data in two lethal orthopoxvirus animal models, i.e rabbitpox model & mousepox model evaluating Tembexa (100 mg, PO, tablets & 10 mg/mL oral suspension dosed, given once weekly for 2 wks.) vs PBO in adult & pediatric patients with Smallpox
  • The studies for each model showed that the therapy resulted in significant survival, following delayed treatment after animals were infected with a lethal viral dose.
  • Tembexa is the First smallpox antiviral approved for all age groups, including infants, and patients who have difficulty in swallowing. The therapy is being developed under an ongoing collaboration with BARDA

Novo Nordisk's Wegovy (semaglutide, 2.4mg) Receives the US FDA's Approval for Weight Management in Adults with Obesity

Published: Jun 7, 2021 | Tags: Novo Nordisk, Wegovy, semaglutide, US, FDA, Approval, Weight Management, Obesity

  • The approval is based on the results from the P-IIIa STEP clinical trial program evaluating Wegovy (2.4mg injection, qw) in ~4,500 adults with obesity or overweight with at least one weight-related comorbidity
  • Results: the therapy showed 17-18% average weight loss in people without T2D @68wks. and has a safe and well-tolerated profile across the program
  • Wegovy is the first GLP-1 receptor agonist and is expected to launch in the US in Jun'2021. The therapy is currently under regulatory review in the EU and other countries

Biogen and Eisai's Aduhelm (aducanumab-avwa) Receive the US FDA's Accelerated Approval for Alzheimer Disease

 Published: Jun 8, 2021 | Tags: Biogen, Eisai, Aduhelm, aducanumab-avwa, US, FDA, Accelerated Approval, Alzheimer Disease

  • The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of Aduhelm vs PBO in patients with early stages of AD with confirmed presence of amyloid pathology
  • Results: the therapy consistently showed a dose and time-dependent effect on the reduction of amyloid-beta plaques by 59 % in ENGAGE, 71% in EMERGE, and 61% in PRIME, reduction in clinical decline, and well-characterized safety profile in ~ 3,000 patients who received at least one dose of Aduhelm
  • Biogen will conduct a controlled trial to verify the clinical benefit of the therapy in patients with AD

Gilead's Epclusa (Sofosbuvir/Velpatasvir) Receives the US FDA's Approval for Children with Chronic Hepatitis C Infection

Published: Jun 11, 2021 | Tags: Gilead, Epclusa, Sofosbuvir, Velpatasvir, US, FDA, Approval, Chronic Hepatitis C Infection

  • The US FDA has approved the NDA of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) for children aged 3 yrs. who cannot swallow tablets
  • The approval is based on a P-II trial evaluating Epclusa in 41 children with HCV for 12 wks. The study showed 83% SVR rate, 88% in HCV genotype 1, 50% in HCV genotype 2, and 100% in HCV genotype 3 & 4, discontinued treatment within one to 20 days of starting treatment who did not achieve cure
  • The expanded approval and oral pellet formulation of Epclusa will help children living with HCV, regardless of HCV genotype or liver disease severity

Eton's Rezipres (ephedrine hydrochloride injection) Receives the US FDA's Approval for the Treatment of Hypotension

Published: Jun 15, 2021 | Tags: Eton, Rezipres, ephedrine hydrochloride injection, US, FDA, Approval, Hypotension

  • The US FDA has approved Rezipres for the treatment of hypotension that occurs in the setting of anesthesia
  • Rezipres is a sulfite-free formulation that has been sold successfully in the EU for years. Additionally, the company is expected to make it available for US patients shortly
  • Currently, the company receives royalties from four FDA-approved products, including Alkindi Sprinkle, Biorphen, Rezipres, and Alaway Preservative Free, and has five additional products that have been submitted to the FDA

Jazz's Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Receives the US FDA's Approval for Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Published: Jun 15, 2021 | Tags: Jazz, Rylaze, asparaginase erwinia chrysanthemi, US, FDA, Approval, Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma

  • The approval is based on clinical data from an ongoing P-II/III JZP458-201 trial evaluating Rylaze in pediatric and adult patients aged =1mos. with ALL or LBL who are allergic to the E. coli-derived asparaginase. Rylaze has approved under the RTOR program
  • Additionally, recent data from a Children's Oncology Group retrospective analysis in ~8,000 patients showed that the patients without asparaginase treatment due to associated toxicity had lower survival outcomes
  • The therapy is expected to be commercially available in mid-July in the US. The FDA has granted ODD to Rylaze for ALL/LBL in June'21 & FTD in Oct'19

Sarfez's Soaanz Receives the US FDA's Approval for the Treatment of Heart Failure and Renal Disease

Published: Jun 21, 2021 | Tags: Sarfez, Soaanz, US, FDA, Approval, Heart Failure, Renal Disease

  • The US FDA has approved Soaan for the treatment of heart failure & renal disease. The therapy offers a new treatment option for heart failure patients who experience persistent edema, swelling in the lower limbs & abdomen despite a loop diuretic therapy
  • The approved drug also provides an alternative treatment for both chronic kidney disease & heart failure patients who skip loop diuretic treatment due to excessive urination
  • Soaanz (PO, qd, tablet) is an improved formulation of the loop diuretic torsemide that provides a longer duration of peak effect without causing excessive urination. The company plans to launch the therapy in the next few mos.

Related Post: Insights+: The US FDA New Drug Approvals in May 2021


Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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