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

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

  • The US FDA has approved 7 NDAs in May 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 33 novel products in 2022
  • In May 2022, the major highlights drugs were Lilly's Mounjaro (tirzepatide) received the US FDA’s approval for the treatment of adults with Type 2 Diabetes, Dermavant’s Vtama (tapinarof) Received the US FDA’s approval for the treatment of Plaque Psoriasis in adults
  • PharmaShots has compiled a list of a total of 7 new drugs approved by the US FDA in May 2022

Phathom’s Voquezna Triple PAK & Voquezna Dual PAK Receives the US FDA’s Approval for the Treatment of H. pylori Infection in Adults

Voquezna Triple PAK & Voquezna Dual PAK

Active ingredient: vonoprazan; amoxicillin; clarithromycin                      Approved: May 03, 2022

Company: Phathom Pharmaceuticals                                                          Disease: H. pylori Infection

  • The approvals were based on P-III (PHALCON-HP) trial evaluating Voquezna Triple & Dual PAK vs lansoprazole triple therapy in 1046 patients with H. pylori inf. The therapies are expected to be available in the US in Q3’22
  • The results from both Voquezna treatment regimens showed non-inferiority over lansoprazole triple therapy in patients without a CAM or AMX resistant strain of H. pylori at baseline in modified ITT population, eradication rate (84.7% & 78.5% vs 78.8% & 78.8%), superior eradication rates over PPI-based triple therapy in patients with CAM resistant strains of H. pylori
  • In the overall study population, eradication rate (80.8% & 77.2% vs 68.5% & 68.5%) who had a CAM-resistant strain of H. pylori (65.8% & 69.6% vs 31.9%, & 31.9%), respectively

Zydus’ Bortezomib Receives the US FDA’s Approval for the Treatment of Cancer


Active ingredient: Bortezomib                                                                      Approved: May 03, 2022

Company: Zydus Lifesciences                                                                     Disease: H. pylori Infection

  • The company has received the US FDA approval to manufacture and market Bortezomib for inj. 3.5 mg/vial (single-dose vial) to be bioequivalent and therapeutically equivalent to the Velcade to treat cancer incl. multiple myeloma and mantle cell lymphoma
  • The drug will be manufactured at Zydus Hospira. The medication works by slowing or stopping cancer cell growth
  • The company has manufacturing and research facilities in five Indian states: Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim along with US and Brazil. Zydus' global business is well-established in regulated markets i.e., the US, EU (France and Spain), and the high-profile markets of Latin America and South Africa

Mitsubishi Tanabe Pharma America’s Radicava ORS (edaravone) Receives the US FDA’s Approval for the Treatment of ALS

Radicava ORS

Active ingredient: edaravone                                                                      Approved: May 13, 2022

Company: Mitsubishi Tanabe Pharma America                                        Disease: Amyotrophic Lateral Sclerosis

  • The approval was based on the multiple studies i.e., 7 P-I pharmacology studies to evaluate PK, safety, drug-to-drug interactions, dosing, bioavailability & bioequivalence of Radicava ORS vs PBO along with P-III (MCI186-19) trial in patients with ALS. The therapy is as effective as the US FDA-approved Radicava
  • The results showed a 33% reduction in loss of physical function @24wks. as measured by the ALSFRS-R. The P-III (MCI186-19) trial showed a safety & tolerability profile in 185 patients with ALS, AEs were reported in ≥10% of patients with Radicava
  • The company launched the JourneyMate Support Program which provides educational support & resources to patients who are considering or have been prescribed an MTPA product

Lilly's Mounjaro (tirzepatide) Receives the US FDA’s Approval for the Treatment of Adults with Type 2 Diabetes


Active ingredient: tirzepatide                                                                     Approved: May 16, 2022

Company: Lilly                                                                                            Disease: Type 2 Diabetes

  • The approval was based on the P-III (SURPASS) program that consists of (SURPASS-1/2/3/4/5) evaluating Mounjaro (5/10/15mg) as monothx. & as an add-on therapy vs Semaglutide, insulin glargine & insulin degludec in patients with T2D. The therapy is expected to be available in the US in the coming wks.
  • The results showed avg. A1C reductions b/w 1.8% & 2.1% for Mounjaro 5mg & b/w 1.7% & 2.4% for 10 & 15mg dose while greater weight reductions in a 2EPs in all studies
  • Tirzepatide is under regulatory review in the EU, Japan & multiple other countries. The company will engage with insurers, health systems & providers to offer patients access to Mounjaro & plans to offer a Mounjaro savings card to qualified patients

Siga’s Tpoxx (tecovirimat) Receives the US FDA’s Approval for the Treatment of Small Pox


Active ingredient: tecovirimat                                                                  Approved: May 19, 2022

Company: SIGA Technologies                                                                 Disease: Small Pox

  • The US FDA has approved Tpoxx as an IV formulation for smallpox caused by the variola virus in adults & pediatric patients. The therapy provides an alternative option who are not able to swallow oral capsules of Tpoxx
  • The approval was based on animal efficacy studies in nonhuman primates & rabbits infected with nonvariola orthopoxviruses that were adequate & well-controlled
  • Tpoxx is a novel small-molecule drug that prevents the formation of secondary viral envelopes in the variola virus and other poxviruses, thereby inhibiting viral maturation. The therapy has been approved in the US, Canada & EU for smallpox & is also indicated to treat monkeypox, cowpox & complications from immunization with vaccinia in the EU

United Therapeutics’ Tyvaso DPI Receives the US FDA’s Approval for Treatment of PAH and PH-ILD

Tyvaso DPI

Active ingredient: Treprostinil                                                                Approved: May 24, 2022

Company: United Therapeutics                                                             Disease: PAH and PH-ILD

  • The approval was based on the (BREEZE) open-label study evaluating Tyvaso DPI in 51 patients with PAH. Additionally, commercialization activities are currently underway with patient availability is expected in June 2022
  • The results from the patients with PAH who were transitioned from Tyvaso inhalation sol. to Tyvaso DPI demonstrated safety and tolerance @3wk. treatment period, improvements in six-minute walk distance, device preference and satisfaction & PROs
  • Tyvaso DPI marks the first US FDA-approved dry powder inhaler therapy & is indicated for use in PAH and PH-ILD and represents a new formulation and inhalation device for inhaled treprostinil

Dermavant’s Vtama (tapinarof) Receives the US FDA’s Approval for the Treatment of Plaque Psoriasis in Adults


Active ingredient: tapinarof                                                                   Approved: May 24, 2022

Company: Dermavant Sciences                                                           Disease: Plaque Psoriasis

  • The P-III (PSOARING 1 & 2) trial met all 1EPs & 2EPs i.e., Vtama showed an improvement in PGA 6 score of “clear” or “almost clear” with a minimum 2-grade improvement (36% & 40% vs 6% & 6%) @12wks., ≥75% improvement in PASI-75 from baseline
  • 92% were enrolled in the P-III LTE study who completed (PSOARING 1 & 2) trial, 40% of LTE study patients achieved complete disease clearance, remitting effect with a median duration of ~4mos. while in off-therapy was 130 days who achieved a clear skin PGA score of 0 or 1
  • The safety & tolerability was consistent with PSOARING 1/2/3 study. Patient satisfaction data from the P-III LTE study showed that 81.7% considered it more effective than prior topical treatments. The product is expected to be available in June 2022

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

Senior Editor

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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