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Pfizer and Lilly’s JAK Inhibitors Safety Concerns Prompt Europe to Investigate the Drug Class
The risk of heart problems associated with the use of JAK inhibitors has called the entire drug class into question. In September, the FDA announced that it would require safety warnings for drugs such as Pfizer’s Xeljanz, Eli Lilly’s Olumiant, and AbbVie’s Rinvoq. It is now up to Europe to conduct a more thorough examination of the treatments.
The European Medicines Agency has announced on Friday that it’s Pharmacovigilance Risk Assessment Committee (PRAC) would look at all JAK inhibitors following the recent findings of a clinical trial of the Xeljanz, which showed recipients were more likely to experience cardio problems such as heart attack, stroke, or death due to cardiovascular disease.
The trial also revealed that patients who received TNF inhibitor drugs, such as AbbVie’s Humira, had a greater risk of developing cancer. Xeljanz has also been linked to an increased risk of death from any cause, including blood clots in the lungs, infection, and deep vein thrombosis. The EMA further stated that its decision to conduct a JAK review stems from its preliminary examination of another Rheumatoid Arthritis drug, Olumiant. An observational study also indicates a higher risk of major cardiovascular issues and deep vein thrombosis.
Furthermore, Pfizer first warned about heart-related safety concerns associated with the trial’s 10-mg Xeljanz dose in 2019. The FDA noticed and slapped a warning label on the drug, citing an increased risk of blood clots and death. The EMA then imposed a similar but slightly different restriction.
The restrictions and scrutiny have only recently begun to impact the use of Xeljanz. Xeljanz sales have levelled off after years of steady growth since its approval in 2012. Xeljanz’s sales increased to USD 2.45 billion in 2021, up from USD 2.44 billion in 2020.
The FDA Approves Lilly’s New Antibody Drug, Bebtelovimab, Effective Against the Omicron Variant
The FDA has granted emergency use authorization to Eli Lilly’s bebtelovimab, a new COVID-19 monoclonal antibody treatment, one day after the US announced a supply deal for it. Bebtelovimab can be used to treat mild-to-moderate COVID-19 in adults and children aged 12 and above who are at risk of developing severe COVID-19.
It has been demonstrated that the treatment is effective against the omicron variant. The FDA banned Lilly’s antibody cocktail of bamlanivimab and etesevimab three weeks ago after it was shown to be ineffective against omicron. REGEN-COV, Regeneron’s antibody, was also grounded that day for the same reason.
The approved bebtelovimab dose is 175 mg administered intravenously over at least 30 seconds. The dosage is significantly lower and faster to administer than previous COVID-19 antibody treatments.
The approval is based on phase 2 BLAZE-4 trial results, which included nonhospitalized patients who were given bebtelovimab alone or in combination with bamlanivimab and etesevimab. Bebtelovimab retained full neutralising activity against omicron in both pseudovirus and authentic virus testing. Furthermore, the drug neutralised all other known variants of interest, including omicron’s emerging subvariant BA.2.
The United States has agreed to pay USD 720 million for bebtelovimab. Lilly will provide 600K treatment courses, 300K this month and 300K by the end of next month. The US will have the option to purchase 500K more antibody courses, which will be delivered by July 31.
China Approves Gsk’s Benlysta For the Treatment Of Lupus Nephritis
The National Medical Products Administration (NMPA) of China has accepted Benlysta (belimumab) for the cure of adult patients suffering from active lupus nephritis (LN) who are receiving standard of care, according to GlaxoSmithKline plc (GSK). The approval expands the current indication in China for adults and children aged five and up with active Systemic Lupus Erythematosus (SLE) as add-on therapy. Belimumab is now the first and only biological drug license in China for Systemic Lupus Erythematosus and Lupus Nephritis.
The NMPA granted approval based on findings from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) phase III trial, which demonstrated that adding belimumab to standard therapy increased renal response rates and reduced the risk of kidney disease worsening in patients with active Lupus Nephritis over two years.
With 448 adult patients, the BLISS-LN phase III trial is the largest and longest inactive Lupus Nephritis trial ever conducted. The trial met its primary endpoint, showcasing that in adults with active Lupus Nephritis, belimumab plus standard of care resulted in a statistically significant and clinically meaningful higher number of patients achieving Primary Efficacy Renal Response (PERR) at two years when compared to placebo plus standard of care.
Belimumab is also approved in China for active and autoantibody-positive Systemic Lupus Erythematosus with high disease activity in combination with standard of care in patients aged five and older. It’s also the first biologic for pediatric SLE on China’s National Reimbursement Drug List for 2021.
Russia Approves Daewon’s Non-Steroidal Anti-Inflammatory Drug
Pelubi, Daewon Pharmaceutical’s non-steroidal anti-inflammatory medicine (NSAID), has received permission from the Russian Federation’s Ministry of Health and launched under the brand name Pelubio.
Pelubi will be made at Daewon’s plant in Gyeonggi Province and sent to Russia. Pharmstandard, Russia’s second-largest pharmaceutical distributor, would promote the medicine through its extensive distribution network, according to the Korean firm.
Daewon intends to ship three million tablets in the first half of this year, increasing volume in response to market demand. After completing local clinical studies, the company signed an export contract for a sustained-release (SR) tablet form of Pelubi and aims to export it as soon as feasible.
Russia mandates local clinical trials for all export items and makes due diligence of manufacturing sites extremely tough. As a result, the proportion of raw materials exported to the country is substantially higher than that imported completed medications.
Daewon has been watching Russia as a typical pharmerging market, with an annual growth rate of 12.8% to 26 trillion won ($2.1 billion), making it the largest in Central Asia and Eastern Europe. NSAIDs have a market value of almost 550 billion won, and demand is growing.
The company intends to construct and develop various marketing methods tailored to local conditions, including conducting a symposium in Russia to coincide with the product’s launch.
“By marketing Korea’s novel pharmaceuticals abroad and demonstrating their brilliance through local clinical trials, our export to Russia is significant. As a result, we anticipate to be able to compete effectively in the worldwide market, “Paik Seung-yeol, vice president of Daewon Pharmaceutical, stated. “We will continue to build export channels to additional pharmerging markets in Central Asia and Eastern Europe, using Russia as a foundation.”
Pelubi, Korea’s 12th unique medicine, was first presented as an NSAID in 2007 and has since been expanded to include a variety of applications. As a result, the therapy has the highest prescription sales among NSAIDs, with approximately 30 billion won in yearly sales.
FDA Advisors Call for a New Trial of Lilly & Innovent’s Lung Cancer Drug
The US Food and Drug Administration has rejected Eli Lilly &Innovent Biologics’s lung cancer treatment. The Oncologic Drugs Advisory Committee (ODAC) voted 14-1 against the drug as it was tested only in China and the population was not as diverse as that in the U.S. Additionally, it cited the non-applicability of the results in the US. The committee recommended that Lilly & Innovent conduct additional clinical trials in the US patients to receive final approval.
The lung Cancer drug in discussion is a monoclonal antibody treatment Sintilimab, that treats adults with non-small cell lung cancer in combination with pemetrexed and platinum chemotherapy. Sintilimab is already approved in China under the brand name Tyvyt.
As per the DelveInsight, in 2020, the United States had 227,800+ incident cases of Lung Cancer, of which nearly 85%, i.e., 193,000+ were NSCLC patients. It is observed that lung cancer patients in the US. are split equally across genders, and they also represent diverse ethnic backgrounds, which formed the basis for the FDA to reject the drug.
FDA Grants Fast Track Designation to Bayer’s Oral Anticoagulant Asundexian
In the latest clinical updates from the US, Bayer Receives FDA Fast Track Designation for its investigational drug Asundexian (BAY2433334). The Asundexian is an oral inhibitor of Factor Eleven (FXIa) that holds the potential for secondary prevention in patients with an ischemic stroke, specifically those with non- cardioembolic risk factors like narrowed arteries. Asundexian is currently in phase 2 testing as an anticoagulant that could offer safety advantages over existing drugs. Byer is yet to release the phase 2b programme data for the ischaemic stroke, along with two other medical conditions for which the drug is being evaluated.
Stroke is a serious medical condition and a leading cause of death & disability in the US. As per the estimates, nearly 800,000 people suffer from strokes each year in the US, and around 82–92% of these strokes are ischemic. With the fast track designation, now Bayer is set to give a tough fight to its rivals – BMS (Eliquis (apixaban)) and Bayer-J&J (Xarelto (rivaroxaban)), in the strokes therapeutics market.