The European Medicines Agency (EMA) is backing a series of measures to reduce the risk of serious side effects associated with Janus kinase (JAK) inhibitors, limiting their use in high-risk individuals. Similarly, Health Canada is recommending updated labeling for the drug class to disclose the risk of serious cardiovascular events and cancer. The agency is…
FDA approves AbbVie’s Rinvoq for nr-axSpA
FDA has approved AbbVie’s Rinvoq (upadacitinib) for adults with active non-radiographic axial spondyloarthritis (nr-axSpA). The indication covers nr-axSpA patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors. The JAK1 selective inhibitor Rinvoq now has six U.S. indications. The new indication makes Rinvoq the only…
Ultomiris wins approval in Europe for generalized myasthenia gravis
The complement C5 inhibitor Ultomiris (ravulizumab) from AstraZeneca (LON:AZN) has won approval in Europe as adjunctive therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The regulatory nod represents the first approval for a long-acting C5 complement inhibitor for treating gMG in Europe. While myasthenia gravis is a chronic…
Tremfya shows durable efficacy for psoriatic arthritis joint and axial symptoms
Janssen (NYSE:JNJ) has released new data showing the efficacy of the IL-23 inhibitor Tremfya (guselkumab) for a variety of psoriatic arthritis (PsA) symptoms for up to two years. Patients with active psoriatic arthritis treated with guselkumab in Phase 3 studies had consistent, long-term efficacy over two years. Specifically, patients who received the drug had improvements…
Genanscence raises $10.5 million in Series A financing
The clinical-stage biotech Genascence has closed a Series A financing led by Pacira BioSciences, generating $10.5 million. The funding round included investors Polymerase Capital, DeepWork Capital and University of Florida Research Foundation. The Palo Alto, California–based company is focused on treating musculoskeletal diseases with gene therapy. The company plans on using the funding for continued…
FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis
AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine. The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis. The ankylosing spondylitis indication is limited to…
Chinese regulators approve GSK’s Benlysta for lupus nephritis
GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN), a type of kidney disease affecting more than half of those with systemic lupus erythematosus (SLE). Benlysta is the only biologic approved to treat SLE and lupus nephritis…
Network meta-analysis ranks guselkumab best for skin clearance in psoriatic arthritis
A recent comprehensive network meta-analysis (NMA) concluded that Tremfya (guselkumab) from Janssen (NYSE:JNJ) ranked highest for the overall level of skin clearance among 23 treatment regimens for active psoriatic arthritis (PsA). The NMA drew on data from 33 Phase 3 randomized clinical trials. Of those, 15 were targeted PsA therapies such as the IL-23p19 inhibitors such…
Biogen announces biosimilars collaboration deal with Xbrane
Having recently sold an equity stake in Samsung Bioepis for up to $2.3 billion, Biogen (NSDQ:BIIB) has announced a licensing deal with Xbrane Biopharma (STO:XBRANE), a Swedish biosimilar developer. The agreement relates to the development of Xcimzane, a preclinical monoclonal antibody referencing Cimzia (certolizumab pegol) from UCB. Having first won FDA approval in 2018 for moderate to…
Lilly discontinues Olumiant development for lupus
Eli Lilly and Co. (NYSE: LLY) and its partner Incyte (NSDQ:INCY) have decided to halt a Phase 3 program for the oral JAK inhibitor Olumiant (baricitinib), focusing on adults with active systemic lupus erythematosus. The companies reached that conclusion after reviewing data from the SLE-BRAVE I and SLE-BRAVE II Phase 3 trials in adults with…
FDA approves second indication of AbbVie’s Skyrizi for adults with active psoriatic arthritis
FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis. To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies.…
Janssen’s latest Tremfya data could offer hope for subset of psoriatic arthritis
Psoriatic arthritis (PsA) is a complex heterogeneous disease involving the peripheral joints, affecting between 7% and 26% of psoriasis patients. Among the popular treatment options for psoriasis are tumor necrosis factor (TNF) inhibitors. A significant portion of psoriatic arthritis patients, however, fail to respond to TNF inhibitors. Janssen announced last month that Tremfya (guselkumab) fared…
AbbVie files Rinvoq application for non-radiographic axial spondyloarthritis in U.S. and Europe
AbbVie (NYSE:ABBV) has submitted applications asking for approval of upadacitinib (Rinvoq) from the FDA and the European Medicines Agency (EMA) to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). If approved, Rinvoq would be indicated for nr-axSpA patients with objective signs of inflammation with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). The Janus kinase…
FDA approves Pfizer’s tofacitinib for ankylosing spondylitis
Pfizer (NYSE:PFE) has received FDA approval for the supplemental New Drug Application (sNDA) for Xeljanz/Xeljanz XR (tofacitinib) as a treatment of adults with active ankylosing spondylitis (AS). About 350,000 Americans have the condition. The Xeljanz approval covers patients who had an insufficient response or intolerance to one or more tumor necrosis factor (TNF) blockers. Xeljanz…
Janssen upbeat about latest guselkumab data for patients with psoriatic arthritis
Janssen (NYSE:JNJ) recently presented new data on Tremfya (guselkumab) related to active psoriatic arthritis (PsA) at the American College of Rheumatology (ACR) Convergence while also publishing data in Arthritis & Rheumatology. Notably, guselkumab provided durable joint symptom and disease activity improvement with a consistent safety profile through week 100 in adults with active psoriatic arthritis (PsA).…
AbbVie shares new Rinvoq data involving patients with psoriatic arthritis
Abbvie’s (NYSE:ABBV) JAK inhibitor Rinvoq (upadacitinib) beat out placebo at week 24 in posthoc analyses of two Phase 3 studies focused on people with active psoriatic arthritis. In particular, the drug led to a superior clinical response related to axial involvement, which occurs in a substantial portion of people with psoriatic arthritis. Sharing the data…
Kymera Therapeutics shares positive KT-474 data for atopic dermatitis
Kymera Therapeutics (NSDQ:KYMR), like a growing number of biotech companies, is intending to expand the druggable universe. To that end, the company announced positive data related to targeted protein degradation (TPD). This modality enables oral small-molecule drugs to coax the body into clearing disease-causing proteins. Kymera’s lead drug candidate, KT-474, targets a key protein known…
FDA approves first interchangeable Humira biosimilar to Humira
Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales. Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar. First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and…
AbbVie wins CHMP positive opinion to use Skyrizi as an active psoriatic arthritis treatment
AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis. The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one…
AbbVie’s Rinvoq met primary endpoint in ankylosing spondylitis trial
AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae. The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response…
Janssen presents new safety data for Stelara in older patients
Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials. The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from…
Janssen’s Tremfya shows promise in PsA patients with sacroiliitis
A post-hoc analysis published in Lancet Rheumatology suggested that Janssen’s IL-23 inhibitor Tremfya (guselkumab) is effective in treating psoriatic arthritis (PsA) patients with symptoms affecting the spine and sacroiliac (SI) joints. In addition, the patient subset had sustained improvement through 52 weeks. The study focused on psoriatic arthritis patients in the company’s Phase 3 DISCOVER-1 and DISCOVER-2…
Tremfya shows promise in reducing fatigue in PsA patients
Janssen’s Tremfya (guselkumab) was associated with reduced fatigue in two Phase 3 clinical trials involving 1,120 patients with psoriatic arthritis (PsA), according to an article published in Arthritis Research & Therapy. The study found that PsA patients who received 100 mg of guselkumab every four weeks or every eight weeks had clinically meaningful and sustained improvements…
34 of the most innovative pharmaceutical products
The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Olumiant offers hope to patients with rheumatoid arthritis
FDA has indicated Lilly‘s OLUMIANT (baricitinib) to treat adult patients with moderately to severely active rheumatoid arthritis. In particular, the agency has recommended the drug for patients with an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. In June, Lilly and its partner Incyte announced that the drug appeared to reduce…