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Tremfya bests Cosentyx in psoriasis study

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment.

In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 90 and PASI 100). Guselkumab recipients also had higher rates of clear or almost clear skin based on the Investigator’s Global Assessment scores of IGA 0 and IGA 0/1, respectively

The difference in performance between the two drugs was especially pronounced in patients weighing more than 100 kg (220 pounds). For instance, 62.3% of guselkumab recipients weighing 100–110 kg had IGA 0/1 responses at week 48, while 44.4% of secukinumab recipients did.

The findings are significant because people with psoriasis have a higher prevalence and incidence of obesity…

COVID-19 vaccines remain a cash cow for now

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A handful of companies are making billions of dollars in revenues from COVID-19 vaccines. Especially well-positioned is Pfizer, which could earn $33.5 billion in COVID-19 vaccine sales this year, as it announced in its Q2 earnings statement. By contrast, J&J has forecasted $2.5 billion in COVID-19 vaccine sales this year, while AstraZeneca has seen sales of $1.1 billion in the first half of this year, according to Moody’s.

Analysts are divided, however, on how strong vaccine sales will be in 2022 and beyond.

A report from Moody’s predicts that vaccine sales next year will begin to wane given significant vaccine penetration rates and uncertain demand for boosters. Vaccine penetration rates in many G20 countries have already surpassed 60%. As a result, COVID-19 vaccine revenue i…

European regulators offer positive opinion on Janssen’s schizophrenia treatment

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation covers clinically stable adults on 1-month paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate.

Get the full story at our sister site, Drug Delivery Business News.

How Janssen’s twice-yearly schizophrenia drug could help patients

Traditionally, one of the most challenging aspects of treating schizophrenia is medication adherence. Patients who neglect to take their medicine have an elevated risk of relapse, hospitalization and suicide. “There’s a higher likelihood of an exacerbation of the illness occurring,” said Dr. Gustavo Alva, medical director at ATP Clinical Research (Costa Mesa, California).

The problem has led drug companies to develop long-acting formulations of antipsychotics. In that vein, Janssen (NYSE:JNJ) recently announced that it has scored FDA approval for the long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate). The drug is the first twice-yearly injectable treatment for adults with schizophrenia.

[Related: Janssen wins FDA approval of twice-yearly schizophrenia treatment]

Paliperidone is the primary active metabolite of Risperdal (risperidone), which first won FDA approval in 1993. The first long-acting injectable of paliperidone palmitat…

ConcertAI and Janssen deepen data-science collaboration

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types.

ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together with ConcertAI providing data, technology and clinical data scientists.

The two companies began working together in late 2019 and have since partnered on a number of programs, some of which progressed to the clinic, regulatory submissions and regulatory approvals.

Elton said that the recent collaboration is “a major expansion of what we first put into place in 2019.”

ConcertAI and Janssen are also working together to support clinical trial diversity. “We’ve been using some specialized data sets to ensure that clinical trials didn’t unwittingly exclude certain racia…

Janssen’s pulmonary hypertension division leader upbeat about the future of PH treatment

A few decades ago, an HIV diagnosis was akin to a death sentence. But with proper treatment including antiretroviral therapy, HIV patients can often expect to have a normal life expectancy.

David Jimenez, former president of Johnson & Johnson’s Janssen Infectious Diseases, is confident that similar breakthroughs can happen in pulmonary hypertension. “We’re not there yet,” said Jimenez, who is now the U.S. president of Janssen’s new Pulmonary Hypertension (PH) division. “That is why our focus is to really improve the lives of patients, and hopefully one day cure it.”

Pulmonary hypertension is a new therapeutic focus for Janssen. Up until recently, Janssen focused on five therapeutic areas: cardiovascular and metabolic diseases, immunology, neuroscience and oncology, and infectious diseases and vaccines.

The company’s 2017 acquisition of Actelion for $30 billion made PH a sixth focus area.

Canada to donate 10 million J&J vaccine doses to developing countries

Initially facing a shortage of COVID-19 vaccines, Canada has now vaccinated a greater share of its population than the U.S.

Now, the country is planning on donating 10 million doses to low- and middle-income countries via the COVAX initiative, a global program that aims to distribute vaccines in developing nations.

The country had faced controversy earlier this year for tapping into a supply of vaccines initially set aside for COVAX.

The Africa Center for Disease Control (AfricaCDC) recently announced that it had chosen the Johnson & Johnson COVID-19 vaccine. The vaccine has the advantage of having straightforward storage requirements and is available as a single dose.

To date, Canada has committed 40 million doses to the COVAX program and additional financial support for the initiative.

In June, Canada rejected some 300,000 doses of U.S.-made Janssen vaccine over potential contamination problems.

WHO to test three anti-inflammatory therapies in COVID-19 patients

The World Health Organization (WHO) is adding three anti-inflammatory therapies to its global Solidarity COVID-19 trial. WHO is referring to the expanded trial as “Solidarity PLUS.”

WHO will investigate the following drugs as potential treatments for hospitalized COVID-19 patients:

Ipca Laboratories’ artesunate is an FDA-indicated treatment for severe malaria in adult and pediatric patients. Last year, the drug became the only drug with that indication. In vivo and in vitro SARS-CoV-2 studies involving artesunate have been promising. A study published in ACS Chemical Neuroscience concluded that the drug could potentially treat neurological symptoms related to COVID-19. Novartis’s Gleevec (imatinib mesylate) is a kinase inhibitor. FDA indications for the drug include a range of cancers, including leukemia and gastrointestinal stromal tumors. A separate group of researchers is also evaluating the safety and efficacy of the drug in hospitalized adults with COVID-19.…

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 studies with axial symptoms and sacroiliitis, an inflammation of one or both of the sacroiliac joints connecting the pelvis to the spine.

Among patients with psoriatic arthritis, sacroiliitis is a relatively common condition. One small study found that 38% of PsA patients had sacroiliitis.

Janssen plans a separate study to bolster the hypothesis that guselkumab improves spinal symptoms associated with psoriatic arthritis.

Tremfya (guselkumab) won FDA approval for adult patients with act…

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 in fatigue through one year.

The results offer hope for PsA patients with disease-mediated fatigue — a symptom that doctors have traditionally underappreciated.

To arrive at their conclusion about guselkumab, the investigators used a mediation analysis, a statistical method that attempts to identify the relationship between variables. In this case, the analysis investigated the relationship between fatigue and a variety of PsA symptoms. Such measures included American College of Rheumatology criteria (ACR20) to measure joint improvement, the presence of C-reactive protein to study in…

Stelara shows promise for long-term management of ulcerative colitis

Janssen’s (NYSE:JNJ) Stelara supported corticosteroid-free remission in about half of ulcerative colitis patients in a 152-week long-term extension UNIFI study.

At the end of the nearly three-year study, 55.2% of volunteers were in symptomatic remission. Of those patients, 96.4% were corticosteroid-free at week 152. Janssen, which is part of Johnson & Johnson, presented the data today at the Congress of the European Crohn’s and Colitis Organisation (ECCO).

Stelara (ustekinumab) enabled more than half of the patients in the trial to achieve remission without the need for steroids. That fact is one of the most critical findings in the recent data, said Dr. Jan Wehkamp, VP and gastroenterology disease area leader at Janssen.

While the human body naturally produces steroids, long-term use of corticosteroids leads to significant side effects in most people. They can lead to everything from high blood pressure, elevated blood sugar, glaucoma and other prob…

Why Janssen believes next-gen drug Tremfya can meet unmet needs in psoriasis and beyond

Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects.

But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught us that psoriasis was an immunologic disease,” said Dr. Lloyd Miller, vice president, immunodermatology at Janssen Research & Development (NYSE:JNJ).

After researchers determined that psoriasis, which affects some 125 million patients worldwide, results from excess inflammatory cytokines, drug developers began to test the potential of inhibitors of tumor necrosis factor (TNF) and interleukin 17 (IL-17) in treating the disease.

FDA approved TNF blockers such as Janssen’s Remicade (infliximab) for psoriasis and psoriatic arthritis in the mid-2000s. IL-17A antagonists …