Immunological
Uptake in immunology, gastrointestinal and dermatology indications have enabled Skyrizi to post 51% year-over-year growth, and overtake sales for biosimilar-challenged stalwart Humira.
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.
Unlike previous deals in this space which were mostly to do with discovering new compounds, the big pharma is paying $150m upfront to license a specific product.
The company presented positive Phase III data at the American Society of Nephrology meeting for the factor B inhibitor in C3G, a rare kidney disease with no approved treatments.
The gene-editing therapy produced functional cures in eight of 11 patients receiving the go-forward 50mg dose, but the rate fell short of what some investors had hoped for.
The dermatology specialist updated investors on the launch of its first biologic drug, the IL-31 inhibitor Nemluvio, during its third quarter update.
The company announced positive interim results for sibeprenlimab, one of seven IgAN candidates in late-stage development from multiple manufacturers.
The companies presented data for Uplizna and nipocalimab in gMG at a medical meeting. J&J’s nipocalimab is pending for approval in the disease, while Amgen is working on submitting Uplizna.
Sales of Johnson & Johnson’s Stelara declined 6.6% in the third quarter as the first biosimilars launched in Europe and US sales were softer than expected.
With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.
Deal Snapshot: The Cambridge, UK-based company could be in line for payments just shy of $2bn if its partnership with the US giant comes up trumps.
Rocatinlimab met its Phase III endpoints with results that appear uncompetitive with AD market leader Dupixent, while Uplizna may offer a compelling twice-yearly gMG treatment option.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
The clinical road has been pretty rocky for dapirolizumab pegol but a Phase III win is good news for the limited armamentarium of innovative treatments for lupus and a boost for Biogen’s hopes to expand its presence in immunology.
The Belgian drugmaker’s dual IL-17A and IL-17F inhibitor is now approved for four indications in the US, with another in hidradenitis suppurativa expected soon, and analysts believe that UCB’s peak sales forecast of €4bn could be on the conservative side.
While it waits to see if Fasenra succeeds in a Phase III trial for chronic obstructive pulmonary disease, the UK major has got over the regulatory line in the much smaller but underserved space of eosinophilic granulomatosis with polyangiitis.
The IL-13 inhibitor will go up against Regeneron/Sanofi’s Dupixent. Lilly executives talked to Scrip about the US launch.
A subcutaneous formulation of Roche’s best-selling drug will offer an alternative to a lengthy intravenous infusion. Both versions will be priced the same.
The IL-23 inhibitor was approved by the US FDA for ulcerative colitis, joining AbbVie’s Skyrizi and Lilly’s Omvoh.
New pivotal data on Regeneron and Sanofi’s antibody in chronic urticaria are underwhelming, though probably sufficient for approval. A green light may beckon in bullous pemphigoid, too.