Sub Q Entyvio Hits Speed Bump After US Complete Response
Queries ‘Unrelated’ To Clinical Data
Questions from FDA may delay progress to US approval of Takeda's more convenient formulation of blockbuster Entyvio.
You may also be interested in...
Roche’s etrolizumab missed primary endpoints in its Phase III study program evaluating it as maintenance therapy in moderately to severely active ulcerative colitis, a new therapeutic area for the firm.
Takeda has won EU approval for an injectable version of Entyvio to treat ulcerative colitis or Crohn’s disease, in contrast to the FDA’s rejection in December.
Celltrion plans to launch its new subcutaneous formulation of Remsima in Europe next year beginning with Germany and then to get approvals for all indications by mid-2020. It has indicated that prices will be higher than first-line anti-TNF treatments but competitive with second-line rheumatoid arthritis treatments, as it pursues a strategy to gain substantial market share.