Janssen receives approval from the FDA for its Spravato CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid
FDA has granted accelerated approval to Janssen’s erdafitinib, a treatment for adult patients with locally advanced or metastatic bladder cancer. Which enables the drug to be used to treat bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. The
Experts state that it is looking highly unlikely that Janssen’s Zytiga plus androgen deprivation therapy (ADT) and prednisone/prednisolone will become routinely available on the NHS as a first-line treatment for patients with high-risk hormone-sensitive metastatic prostate cancer. NICE have published draft guidelines rejecting the therapy in this setting, after concluding that the company’s economic
Janssen announces that it has secured recommendation from NICE for Stelara, first of its kind, to treat moderately to severely active Crohn’s disease in adults who have previously proved unresponsive to conventional therapy or a TNFα inhibitor.
With expanded approval of Janssen’s psoriasis blockbuster Stelara, individual patients in the EU with Crohn’s disease have gained possible access a new treatment option. Regulators in Europe have approved use of the biologic as an alternative option for adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost
NICE Issue Draft Guidance for Pfizer’s Lung Cancer Drug but Removes Janssen and Novartis Drugs from Funding.
NICE have issued new draft guidance in the UK meaning some patients with lung cancer will be eligible for treatment with Pfizer’s Xalkori, reversing an earlier rejection. NICE recommended ALK inhibitor Xalkori for NHS use after Pfizer agreed to markdown the drug’s price for the second time. An earlier reduction from its £51,000-a-year UK list