Drugs

Promising Ianalumab Data for Thrombocytopenia: Novartis

Novartis is reporting that its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who had previously received corticosteroids. The finding comes from the Phase 3 VAYHIT2 trial and marks another late-stage success for the drug in B cell–driven autoimmune diseases. The trial readout also comes one day after Novartis announced promising data from a separate Phase 3 trial of the drug in Sjögren’s disease (see story).

In the study, ianalumab plus eltrombopag outperformed placebo plus eltrombopag in maintaining safe platelet levels over time, which is the trial’s primary endpoint, according to the company. The combination also achieved a significantly higher rate of sustained platelet count improvement at six months, meeting the key secondary endpoint. Novartis says the safety profile was consistent with prior studies and revealed no new safety concerns.

ITP is a rare autoimmune disorder in which the immune system attacks and destroys platelets, increasing the risk of bleeding, bruising and fatigue, according to Novartis. While existing therapies can raise platelet counts, many patients require lifelong treatment, cycling through multiple drugs to keep the disease under control.

Full results from the trial will be presented at an upcoming medical meeting and are expected to support future regulatory submissions in 2027, Novartis says.

The drug, originally developed in collaboration with MorphoSys AG (acquired by Novartis in 2024), is being investigated in multiple autoimmune diseases, including Sjögren’s disease, systemic lupus erythematosus, lupus nephritis, warm autoimmune hemolytic anemia, and diffuse cutaneous systemic sclerosis. Positive Phase III results in Sjögren’s disease were announced earlier this year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome