# FDA Approvals of Biologics in 2022
## 4 Therapeutic Indications and Mechanisms of Action
### Autoimmune Conditions
In trials, ulbituximab has been demonstrated to be superior to an orally administered medication (terifluomomide) in the two endpoints evaluated. In the primary endpoint in trial I, the Annualized Relapse Rate (ARR) reported was 0.08 for ulbituximab vs. 0.19 for terifluomomide, and in the same endpoint in trial II, it was 0.09 for ulbituximab vs. 0.18 for terifluomomide. In the secondary endpoint in trial I, the average number of gadolinium-enhancing lesions was measured at 0.02 for ulbituximab vs. 0.49 for terifluomomide 0.49, and in trial II it was 0.01 for ulbituximab vs. 0.25 for terifluomomide, demonstrating lower rates and fewer lesions in the magnetic resonance imaging [64]. TziieldTM (teplizumab) binds to its target CD3 and patients with Stage 2 type 1 diabetes (T1D) can benefit from a delay in the onset of Stage 3. This is a first-in-class and unique treatment that can deactivate certain immune cells involved in T1D. The efficacy of teplizumab in delaying the onset of Stage 3 T1D has been demonstrated in trials. Indeed, the primary measure was time from randomization to the diagnosis of Stage 3 T1D. It was observed that 19.8 (45%) of the patients (of a total of 44) receiving teplizumab had a later diagnosis of Stage 3 T1D than the placebo group [57; 58; 65]. Teplizumab is intravenously administered and it is one of the few Biologics authorized in 2022 for both adult and pediatric patients. Another important advancement in autoimmune diseases this year is the first-in-class EnjaymoTM (sutlimimbab), which is intravenously administered. It is indicated to decrease the need for red blood cells (RBCs) transfusion in cold agglutini disease (CAD); CAD is a rare condition characterized by the destruction of RBCs in cold temperatures. Sutimlimb also brings a new mechanism of action by binding to the complement protein component 1, inhibiting the complement pathway [56; 66]. In a clinical trial, more than half the patients positively responded to sutimlimb by increasing hemoglobin and no RBC transfusion was required after five weeks of treatment, and they reported decreased fatigue [67; 68]. From 2015 to 2021, the FDA approved 13 Biologics for autoimmune conditions; as such, this is the second disease category to receive the most authorizations after cancer [1]. This year, we have seen four new Biologics added to this category. Ongoing Clinical Trials for the New Biologics for Autoimmune Conditions  
Boehringer Ingelheim is conducting studies to test spesolimab in other conditions. There are trials ongoing to test the efficacy of spesolimab for palmol plantar pustulosis (PPP) in a phase IIa study, with results supporting its efficacy vs. the placebo, but there are still trials ongoing to keep testing for PPP [69; 70]. In 2024, a phase 2 study is expected to be completed to test the efficacy of Spesolimab in hriddenitis suppurativa (HS) [71], ulcerative colitis (UC) [72], an improvement of the narrowing of the small bowel in [PERSON]'s disease patients [73], and there are also studies ongoing to test it in atopic dermatitis (AD) and other conditions whose mechanism is similar to those that can cause HC, UC, or AD [74; 75]. Ublituximab is being tested in combination with umbralisib for proggressive CLL in a phase 2 trial, and in a phase 1 and 2 study testing tacemetostat in combination with umbrasilib and ulbituximab to treat relapsed or refractory follicular lymphoma [76; 77]; no results have been posted yet for either study. Regarding teplizumab and sutimlimb, ongoing trials were not found for diseases other than the primary authorized ones described in the Prescribing Information.