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Insights+: The US FDA New Drug Approvals in April 2022

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Insights+: The US FDA New Drug Approvals in April 2022

Insights+: The US FDA New Drug Approvals in April 2022

  • The US FDA has approved 6 NDAs in Apr 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 26 novel products in 2022
  • In Apr 2022, the major highlights drugs were Vivjoa for Recurrent Vulvovaginal Candidiasis, Cuvrior for Stable Wilson’s Disease, Igalmi for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder
  • PharmaShots has compiled a list of a total of 6 new drugs approved by the US FDA in April 2022

Novartis’ Vijoice (alpelisib) Receives the US FDA’s Approval for the Treatment of PIK3CA-Related Overgrowth Spectrum

Vijoice

Active ingredient: alpelisib                                          Approved: April 7, 2022

Company: Novartis                                                       Disease: PIK3CA-Related Overgrowth Spectrum

  • The US FDA approval was based on RWE from the (EPIK-P1) study evaluating Vijoice in adult & pediatric patients aged ≥2yrs. with PIK3CA-related overgrowth spectrum
  • The results showed a 74% reduction in target lesion volume with a mean reduction of 13.7%, 27% with a confirmed response with ≥20% reduction in PROS target lesion volume @24wk., no patients experienced disease progression at the time of primary analysis
  • Additionally, improvements in pain (90%), fatigue (76%), vascular malformation (79%), limb asymmetry (69%) & disseminated intravascular coagulation (55%). The company provides a patient support program including assistance to access medication, financial resources & continued education

BioXcel Therapeutics’ Igalmi (dexmedetomidine) Receives the US FDA’s Approval for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder

Igalmi

Active ingredient: dexmedetomidine                              Approved: April 7, 2022

Company: BioXcel Therapeutics                                     Disease: Agitation

  • The approval was based on the (SERENITY I & II) studies evaluating Igalmi vs PBO in patients with agitation associated with schizophrenia & bipolar I or II disorder. The product is expected to be available in the US in Q2’22 
  • Both trials met its 1EPs & 2EPs i.e., both (120 & 180mcg) doses showed improvements from baseline along with a high response rate & demonstrated a rapid onset of action @20min. for both 180 & 120mcg doses in (SERENITY II) study while 20 & 30min. in (SERENITY I) study, respectively
  • The results from the P-III (SERENITY II) trial in bipolar disorders were published in the JAMA. Igalmi can be self-administrated by patients under the supervision of a healthcare provider

Sol-Gel Technologies and Galderma’ Epsolay Receive the US FDA’s Approval for the Treatment of Inflammatory Lesions of Rosacea in Adults

Epsolay

Active ingredient: benzoyl peroxide                                  Approved: April 25, 2022

Company: Sol-Gel Technologies and Galderma               Disease: Inflammatory Lesions of Rosacea

  • The approval was based on the two P-III trials to evaluate Epsolay vs vehicle cream in patients with inflammatory lesions of rosacea
  • The coprimary EPs in both trials were the proportion of patients with treatment success & the absolute change from baseline in lesion counts @12wk. the therapy was effective @ 4wks. of treatment, 70% vs 38-46% reduction in inflammatory lesions of rosacea & 50% were clear or almost clear over 38-46% with PBO @12wk. Post-hoc analysis of lesion count & IGA success demonstrated a greater treatment effect as early as 2wk.
  • In the OLE study, 73% were clear or almost clear @52wks. Epsolay (benzoyl peroxide, cream 5%) uses microencapsulation technology & is patent protected until 2040

Mycovia’ Vivjoa (oteseconazole) Receives the US FDA’s Approval for the Treatment of Recurrent Vulvovaginal Candidiasis

Vivjoa

Active ingredient: oteseconazole                                    Approved: April 28, 2022

Company: Mycovia                                                           Disease: Recurrent Vulvovaginal Candidiasis

  • The approval was based on 3 P-III trials i.e., two (VIOLET) & 1 US (ultraviolet) study evaluating oteseconazole vs PBO in 875 patients with RVVC at 232 sites across 11 countries. Vivjoa is expected to be available in Q2’22
  • The results from 2 (VIOLET) studies showed that (93.3% & 96.1% vs 57.2% & 60.6%) of women achieved a reduction of RVVC recurrence for 48wk. maintenance period. In the (ultraVIOLET) study, 89.7% vs 57.1% of women cleared initial yeast infection & did not have a recurrence for 50wk. maintenance period along with sustained efficacy
  • Vivjoa is the 1st US FDA approved product & an azole antifungal that was indicated to reduce the incidence of RVVC in females

BMS’ Camzyos (mavacamten) Receives the US FDA’s Approval for the Treatment of Symptomatic New York Heart Association Class II-III Obstructive HCM

Camzyos

Active ingredient: mavacamten                                   Approved: April 29, 2022

Company: BMS                                                             Disease: NYHA class II-III obstructive HCM

  • The approval was based on the P-III (EXPLORER-HCM) trial to evaluate Camzyos vs PBO in a ratio (1:1) in 251 adult patients with NYHA class II-III obstructive HCM to improve functional capacity & symptoms
  • The results showed that 37% vs 17% of patients achieved the composite 1EPs @30wk., greater improvement across all 2EPs including mean change from baseline post-exercise LVOT peak gradient & pVO2, improvement of NYHA class ≥1 (65% vs 31%)
  • Mean change from baseline in KCCQ-23 † CSS, KCCQ-23 TSS & KCCQ-23 PL, mean resting LVEF was 74% at baseline in both groups, 6% vs 2% experienced reversible reductions in LVEF to <50%. The company offers multiple programs and resources along with patients support

Orphalan’s Cuvrior Receives the US FDA’s Approval for the Treatment of Adult Patients with Stable Wilson’s Disease

Cuvrior

Active ingredient: mavacamten                                   Approved: April 30, 2022

Company: Orphalan                                                      Disease: Stable Wilson’s Disease

  • The US FDA has approved Cuvrior for the treatment of adult patients with stable WD who are de-coppered & tolerant to penicillamine
  • The approval was based on data on the P-III (CHELATE) study to evaluate Cuvrior vs penicillamine in 53 adults with WD. The trial met its primary efficacy EPs i.e., Cuvrior was found to be non-inferior to penicillamine & showed that patients treated with Cuvrior had a similar mean NCC level to penicillamine @36wks., Cuvrior treated patients had a lower mean 24hr. urine copper excretion than penicillamine
  • Cuvrior is a functionally scored tablet that contains 300mg trientine tetrahydrochloride. The product is expected to be available in early 2023

Related Post: Insights+: The US FDA New Drug Approvals in March 2022


Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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