Insights+: EMA Marketing Authorization of New Drugs in October 2022

The EMA approved 2 Biologic Drugs in October 2022, leading to treatments for patients and advances in the healthcare industry
In October 2022, the major highlights drugs were Yescarta approval for diffuse large B-cell lymphoma and high-grade B-cell lymphoma, and Adtralza for atopic dermatitis
PharmaShots has compiled a list of a total of 2 new drugs approved by the EMA in October 2022

1. Kite’s Yescarta Receives EC’s Approval as 2L Treatment of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma


     Active ingredient: axicabtagene ciloleucel                                       Approved: October 18, 2022

     Company: Kite Pharma                                                                       Disease: B-cell Lymphoma

The EC has granted approval to Yescarta for adult patients with DLBCL and HGBL who relapse within 12mos. from completion or are refractory to 1L chemoimmunotherapy 
The approval was based on the P-III (ZUMA-7) study evaluating Yescarta vs SoC in 359 adult patients with r/r LBCL within 12mos. at 77 centers. The study showed a ≥4-fold improvement in 1EPs of EFS (8.3mos. vs 2.0mos.) at a median follow-up of 2yrs. & had a safety profile that was consistent with prior studies
Additionally, a 2.5-fold increase in patients who were alive @2yrs. without disease progression or need for additional treatment (41% v 16%). The results were consistent in patient subgroups, grade ≥3 CRS & neurologic events (6% & 21%) with no grade 5 CRS or neurologic events 

 2. LEO’s Adtralza Receives EC’s Approval for the Treatment of Moderate to Severe Atopic Dermatitis


     Active ingredient: tralokinumab                                                     Approved: October 21, 2022

     Company: LEO Pharma                                                                     Disease: Atopic Dermatitis

The approval was based on the P-III (ECZTRA 6) trial evaluating the safety & efficacy of Adtralza monothx. (150/300mg) vs PBO in adolescents (n=289) aged 12-17yrs. with moderate-to-severe AD who were candidates for systemic therapy
Post-washout period patients were given Adtralza (Q2W) or PBO initially for 16wks. & dosing of Adtralza started with 300 or 600mg on day 0 for patients receiving 150/300mg, Q2W. Patients responding to Adtralza @16wks. with an IGA score of 0/1 and/or 75% EASI change from baseline were randomized to Adtralza (Q2W/Q4W) for an additional 36wks.
Adtralza is a high-affinity human mAb that binds to & inhibits the IL-13 cytokine responsible for the immune & inflammatory processes underlying AD, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits

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