Novartis' iptacopan demonstrates superiority over anti-C5 treatment in Phase III

Novartis (NOVN: VX) saw its shares edge up 1% to 77.33 francs this morning, after the Swiss pharma giant released top-line clinical trial results showing the its hemoglobinuria treatment candidate iptacopan showed superiority over Alexion and AstraZeneca’s (LSE: AZN) blockbuster drugs Soliris (eculizumab) and Ultomiris (ravulizumab), the current standard of care treatments for the condition.

According to Evaluate analysts, iptacopan, which is also being tested in other indications, has been projected to have net present value of $4.1 billion for the company.

Novartis revealed that the pivotal Phase III APPLY-PNH trial met its two primary endpoints, showing that its investigational oral monotherapy iptacopan was superior to anti-C5 therapies (eculizumab or ravulizumab) in adults with paroxysmal nocturnal hemoglobinuria (PNH) experiencing residual anemia despite prior treatment with anti-C5s. Detailed results will be presented at an upcoming medical meeting and included as part of global regulatory submissions in 2023.