HOT & NOT

Gilead Science’s Galapagos-partnered oral JAK inhibitor filgotinib has been approved in Europe under the brand name Jyseleca for the treatment of moderate-to-severe active rheumatoid arthritis (RA), in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. The drug can be used as a monotherapy or in combination with methotrexate, an immune system suppressant. The approval is based on data from over 3,500 patients treated with filgotinib across the Phase III FINCH and phase II DARWIN programmes.

The European Medicines Agency (EMA) has accepted for review the marketing appplication for Biogen and Samsung Bioepis’ biosimilar referencing Genentech's Lucentis (ranibizumab). SB11 – is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, a leading cause of blindness. “We believe our biosimilar offerings are essential as we collaborate with payers and health authorities globally with the goal of creating budget headroom to fund innovation and ensure sustainable healthcare systems,” said the firm's Hee Kyung Kim.

Rizmoic (naldemedine), commercialised in the UK by Sandoz Ltd, will be available on the NHS to treat patients with opioid-induced constipation who have already tried a laxative, following an endorsement by NICE. The drug is an oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved on the back of evidence showing that it increases the frequency of bowel movements compared with no treatment and other PAMORAs. In two studies, 50% of patients taking Rizmoic for 12 weeks achieved the desired outcome, versus 34% of patients taking placebo.

Pfizer’s oral CDK4/6 inhibitor Ibrance (palbociclib) has failed to meet the primary endpoint of improved invasive disease-free survival (iDFS) in early breast cancer. The results come from the Phase III PENELOPE-B trial, which evaluated Ibrance in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer who have residual invasive disease after completing pre-surgery chemotherapy. Full results are to be presented at an upcoming medical congress.

Gossamer Bio lead drug candidate GB001 has failed to hit targets in two mid-stage trials testing its potential in asthma and chronic rhinosinusitis. GB001 blocks the D2 receptor 2, a protein which can induce the inflammatory pathway that causes airway constriction and swelling as well as mucus production. However while not statistically significant positive trends in the asthma trial were observed, such as reductions in asthma worsening and time to first asthma worsening, as well as improvement in lung function.

Vaccinex’ pepinemab has missed key targets in a Phase II trail assessing its use as a treatment for Huntington’s disease trial. Pepinemab is a humanised monoclonal antibody designed to block the activity of semaphorin 4D (SEMA4D), which controls the migration and function of immune and inflammatory cells. The cognitive endpoints of the SIGNAL trial showed a strong trend for beneficial change, but a statistically significant difference was not found between the placebo and pepinemab arms, the firm noted.