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

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

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

  • The US FDA approved 4 NDAs and 1 BLA in July 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 42 novel products in 2022
  • In July 2022, the major highlights drugs were Zonisade's approval for partial seizures in adults and pediatric patients with epilepsy, Opzelura (ruxolitinib) for Vitiligo, Kyzatrex for Hypogonadism
  • PharmaShots has compiled a list of a total of 5 new drugs approved by the US FDA in July 2022

Arcutis’ Zoryve (roflumilast) Receives the US FDA's NDA Approval for Plaque Psoriasis in Individuals Aged ≥12 Years


Active ingredient: roflumilast                                                        Approved: July 1, 2022

Company: Arcutis Biotherapeutics                                               Disease: Plaque Psoriasis

  • The US FDA has approved the NDA for Zoryve (0.3%) for PsO, incl. intertriginous areas in patients aged ≥12yrs. The therapy is expected to be available in mid-August
  • The therapy has been shown to rapidly clear plaques & reduce itch across all areas of the body & was found to be safe & well tolerated in multiple clinical trials with improvements in disease clearance in hard-to-treat areas
  • The company has launched a ZORYVE patient support program that provides access to commercially insured patients to use Zoryve & offers the payer process, lowering the out-of-pocket cost for eligible patients. The company offers Arcutis Cares PAP which will give Zoryve to financially qualified patients who are uninsured or underinsured at free cost

Azurity’s Zonisade Receives the US FDA’s Approval for Partial Seizures in Adults and Pediatric Patients with Epilepsy


Active ingredient: zonisamide                                                     Approved: July 18, 2022

Company: Azurity Pharmaceuticals                                            Disease: Epilepsy

  • The US FDA has approved Zonisade (100mg/5mL) for partial seizures in adults & pediatric patients aged ≥16yrs. with epilepsy who have difficulty in swallowing or are unable to take tablets
  • In the three trials, the efficacy & tolerability of zonisamide has been evaluated. The first study showed significant treatment differences across 100/200/400mg dose levels while in 2nd & 3rd studies, significant differences across 400mg to 600mg dose with no apparent difference b/w qd & BID
  • In an additional analysis of the first 4wks. of treatment, significant differences from PBO b/w 100 & 400mg dose. Zonisade marks the first US FDA-approved oral liquid formulation of zonisamide that helps to reduce the burden & improve treatment adherence

Incyte's Opzelura (ruxolitinib) Receives the US FDA's Approval for the Treatment of Vitiligo


Active ingredient: ruxolitinib                                                       Approved: July 19, 2022

Company: Incyte                                                                           Disease: Vitiligo

  • The approval was based on the P-III (TRuE-V1 & V2) trial evaluating the safety and efficacy of Opzelura vs vehicle in 600+ patients aged ≥12yrs. with nonsegmental vitiligo
  • The results showed a significant improvement in VASI scores representing improvements in facial and total body repigmentation @24 & 52wk. The results were consistent across both studies @24wk., ~30% vs 8% and 13% in (TRuE-V1 & V2) trial & ≥15% vs 2% of patients achieved ≥75% & ≥90% improvement from baseline in F-VASI75 & F-VASI90 @24wk.; ~50% & ~30% @52wk.
  • The company also launched a patient support program i.e., IncyteCARES that provide access to eligible patients to use Opzelura & also offers financial assistance, ongoing education, and resources

GSK’s Benlysta (belimumab) Receives the US FDA’s Approval for the Treatment of Active Lupus Nephritis in Pediatric Patients


Active ingredient: belimumab                                                      Approved: July 27, 2022

Company: GSK                                                                              Disease: Active Lupus Nephritis

  • The US FDA has approved Benlysta (BLyS-specific inhibitor) for the treatment of active LN who received standard therapy in children aged 5 to 17yrs.
  • The main objective of treating lupus nephritis in both adults and children is to maintain renal function while reducing side effects from treatment and associated morbidity
  • Benlysta is a human mAb that binds to soluble BLyS. The therapy has the potential to suppress B cell survival incl. autoreactive B cells and slows down the development of B cells into immunoglobulin-producing plasma cells by binding to BLyS

Marius’ Kyzatrex (testosterone undecanoate) Receives the US FDA’s Approval for the Treatment of Hypogonadism


Active ingredient: testosterone undecanoate                                Approved: July 31, 2022

Company: Marius Pharmaceuticals                                                 Disease: Hypogonadism

  • The US FDA has approved Kyzatrex, an oral testosterone replacement therapy in adult males with hypogonadism. The product is supplied as 100/150/200mg
  • The approval was based on the P-III (MRS-TU-2019EXT) study that evaluated Kyzatrex in 155 hypogonadal males aged b/w 18 & 65yrs. which showed that 88% of patients achieved a 24hr. mean plasma total testosterone concentration within the normal range of 222-800ng/dL on the final PK visit @90 day & had a maximum total testosterone concentration threshold ≤1200ng/dL b/w 1400 & 2000ng/dL, & ≥2000ng/dL at the final PK visit were 88%, 4% & 0%, respectively
  • In exploratory EPs, improvements in QoL, energy/fatigue, erectile function, intercourse satisfaction, and positive mood were observed

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


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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