Among the group, AbbVie's prolific rheumatoid arthritis med Humira drove the largest increase in U.S. drug spending, according to a report released Tuesday. Novartis' Promacta and Biogen's Tysabri clinched the no. 2 and no. 3 spots, respectively. Elsewhere, drugs from Bausch Health, Supernus Pharmaceuticals and Horizon Pharmaceuticals made the list. In addition, another AbbVie med ranked near the bottom of the list.
Fostamatinib is approved for the treatment of chronic immune thrombocytopenia in adults who are refractory to other treatments (in particular to treatment with corticosteroids). The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in an early benefit assessment whether fostamatinib offers an added benefit for these patients in comparison with eltrombopag or romiplostim.
The European Medicines Agency's advisory committee CHMP has confirmed its negative opinion issued in June against approving Novartis' (NVS -0.5%) Revolade (eltrombopag) as add-on treatment in previously untreated patients at least 12 years old with severe aplastic anemia who are not candidates for autologous stem cell transplant
The European Medicines Agency’s (EMA) latest human medicines committee (CHMP) decisions have been announced, including recommendations for three medicines and one rejection for a marketing authorisation. The Committee also recommended granting a marketing authorisation for La Jolla’s Giapreza, among other decisions.
In what some analysts called Dova Pharmaceuticals’ “biggest catalyst to date,” the company won a second FDA nod for its platelet-boosting drug Doptelet, setting the stage for direct competition against Novartis' still-growing blockbuster Promacta.
Enforcement Report - Week of May 29, 2019
Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension
THOUSAND OAKS, Calif., Dec. 19, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Nplate® (romiplostim) to include the treatment of adult patients with immune thrombocytopenia (ITP) who have had ITP for 12 months or less and an insufficient response to corticosteroids, immunoglobulins or splenectomy.
When Novartis paid $16 billion to acquire GlaxoSmithKline’s cancer portfolio back in 2015, it picked up a few drugs that didn’t seem to have quite so clear growth prospects, including Promacta to treat anemia and platelet diseases. But Novartis kept toiling to expand the label for Promacta, which at the time was bringing in about $117 million a year—and there’s new evidence that those efforts are paying off for the company.