How does Empaveli compare to Soliris?

Empaveli and Soliris are both monoclonal antibodies (also called biologics) but Empaveli is more effective than Soliris at treating paroxysmal nocturnal hemoglobinuria (PNH). People administered Empaveli were more likely to have higher hemoglobin levels after 16 weeks than people administered Soliris, with research reporting a difference in hemoglobin level of 3.84 g per decilitre. In addition, 85% of people receiving Empaveli no longer required blood transfusions, compared to only 15% of people administered Soliris.

Is there a difference in side effects between Empaveli and Soliris?

Empaveli was more likely to cause injection site reactions (37% Empaveli vs. 3% Soliris) and diarrhea (22% vs. 3%), but less likely to cause breakthrough hemolysis (10% vs. 23%), headache (7% vs. 23%), and fatigue (5% vs. 15%). There were no cases of meningitis in either group. 71% of people receiving Empaveli experienced normalization of their lactate dehydrogenase levels (LDH) levels within the first 4 weeks that persisted for the length of the trial (16 weeks), compared to only 15% receiving Soliris.

What are Empaveli and Soliris used for?

Empaveli and Soliris are prescription medicines approved to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare acquired, life-threatening disease of the blood that is characterized by the destruction of red blood cells (hemolytic anemia), blood clots (thrombosis), and impaired bone marrow function.

Soliris may also be used to treat:

• Adults and children with atypical hemolytic uremic syndrome (aHUS)
• Adults with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive
• Adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

Empaveli is only approved to treat PNH.

How are Empaveli and Soliris administered?

Empaveli is administered by subcutaneous (just under the skin) infusion and Soliris is given by intravenous infusion (into a vein). People can be taught how to self-administer Empaveli, but Soliris is usually given by a healthcare professional. Empaveli is administered every two weeks and Soliris is given weekly for the first 5 weeks, then two weekly thereafter.

What do Empaveli and Soliris contain?

Empaveli is a brand (trade) name for pegcetacoplan and Soliris is a brand (trade) name for eculizumab. Both Empaveli and Soliris are monoclonal antibodies and may also be called targeted treatments or biologics.

How do Empaveli and Soliris work?

Both Empaveli and Soliris affect the complement system, which is a part of the immune system that enhances (or complements) the ability of antibodies and phagocytic cells to clear microbes and damaged cells from an organism, promote inflammation, and attack the pathogen's cell membrane, but they each work in a slightly different way. Empaveli binds to complement protein C3 and prevents C3 from splitting into C3a and C3b. This helps to stop intravascular hemolysis (IVH or the destruction of red blood cells in the circulation) and extravascular hemolysis (EVH or the breakdown of red blood cells in the spleen, bone marrow, or liver by macrophages). Empaveli is the only treatment that targets C3 and may prevent both forms of red blood cell destruction (IVH and EVH).

Soliris binds to complement protein C5 and prevents it from splitting into C5a and C5b, preventing the generation of the terminal complement complex C5b-9. This helps to stop IVH but not EVH.