Table of Contents
Immunocore Receives FDA Approval for the First Uveal Melanoma Treatment, As Well As the First T-cell Receptor Therapeutics
Uveal Melanoma, an aggressive eye cancer, has proven to be a tough nut to crack for researchers seeking a cure. However, with the approval of a new treatment, those with the disorder will have a better chance of survival. The FDA-approved Immunocore’s Kimmtrak (tebentafusp-tabn), the first T-cell receptor therapeutic for unresectable or Metastatic Uveal Melanoma (mUM) treatment.
The FDA approved the infused treatment a month ahead of schedule and five months after regulators in the United States and Europe approved Immunocore’s biologics license application. The company also anticipates receiving approval from the European Medicines Agency soon and plans to launch in the second quarter of this year. Kimmtrak will cost USD 18K per vial containing a weekly dose. With a median treatment duration of 5.3 months, the average cost per patient will be around USD 400K.
The FDA’s approval of Kimmtrak was based on a Phase 3 trial involving 378 newly diagnosed patients. Kimmtrak, a bispecific T-cell engager, was tested against three established treatments for the disease—two immune checkpoint inhibitors and a chemotherapy drug, depending on the investigator’s preference. Merck’s Keytruda was given to 82% of those in the control group. Kimmtrak had a median overall survival rate of 21.7 months versus 16 months for patients in the control group, with a nearly 50% lower risk of death.
Furthermore, Immunocore has established the Kimmtrak Connect program to assist patients in receiving treatment regardless of their financial situation.
Roche’s newly Approved Vision Drug Aims to Compete Against a Blockbuster
The FDA has authorized Roche’s much-anticipated Faricimab for two major causes of blindness: Wet Age-related Macular Degeneration (Wet AMD) and Diabetic Macular Edema (DME), setting up a commercial battle with Bayer and Regeneron’s market-leading drug Eylea. According to the company, Faricimab is the “first and only” FDA-approved injectable for both Wet AMD and DME that can be given every 4 to 16 weeks, whereas Eylea (aflibercept) must be given every 8 to 12 weeks. Furthermore, Faricimab could be used as infrequently as every 16 weeks for half of the patients and every 3 months for the other three-quarters. As a result, it requires fewer injections into the eye over the course of a year than Eylea and other competing drugs, potentially alleviating the strain on patients while preserving their vision.
The drug demonstrated improved efficacy in a head-to-head trial against Novartis’ Lucentis (ranibizumab), with which Roche partners in some markets, and non-inferiority in two Phase 3 trials comparing it to Eylea in Wet AMD (TENAYA and LUCERNE) and DME (YOSEMITE and RHINE).
Moreover, it could also provide a cost advantage over Eylea. Roche has set a list price of USD 2,190 per dose, which is higher than Eylea’s USD 1,850 but maybe a cheaper option for patients who can be stabilized on less frequent doses.
Novovax Completed Emergency Use Authorization Request To FDA After A Long Run of Delays Leading To Final Filing of COVID-19 Vaccine
Novavax filed the long-awaited EUA to the FDA for their highly anticipated COVID-19 vaccine – NVX-CoV2373 effective for people aged 18 years and older. NVX-CoV2373 is a protein-based shot that is observed to have demonstrated the efficacy of about 90% against symptomatic disease. The results were obtained from large clinical trial studies held in U.S. and Mexico. The vaccine is a two-dose shot that has been praised for its safety and effectiveness, although it definitely faced repeated delays. It is a ‘protein-based’ vaccine that introduces a person’s immune system to inactive virus cells – almost similar to the flu shot and similar mechanism to several other common vaccines, in order to generate a response. Novovax also published its Phase 3 clinical trial findings in the New England Journal of Medicine. Trials included almost 30,000 participants across the U.S. and Mexico whereas a second trial was held for 15,000 participants in the UK. In addition to that, for EUA regulatory submission, a range of preclinical, clinical and manufacturing-related data was included.
Initially, it was hoped that Novavax will file the EUA by the second quarter of last year (2021), but the deadlines were pushed to the third quarter due to some manufacturing malfunctions. Clinical trials were done before the emergence of the Omicron variant, so now the effectiveness against Omicron may be the key as to whether the jab will receive authorization or not. The mild side-effects noted from the jab include nausea, headaches, vomiting, injection site tenderness, slight pain, and fatigue. There’s still a doubtful case of what level of use will the vaccine experience in the future, as there already is immense success found in Pfizer and Moderna’s mRNA-based COVID-19 vaccines.
Samsung Biologics To Shake Hands With Biogen In Agreement For Full Acquisition For Whopping USD 2.3 Billion
Samsung Biologics to acquire Biogen in an agreement with the Samsung Bioepis joint venture for jaw-dropping USD 2.3 billion. This transaction is anticipated to be very fruitful and boost the growth for Samsung Biologics on a consolidated basis, fully capitalizing on Samsung Bioepis’ growth outlook. Initially, Biogen invested an almost 15% stake in Samsung Bioepis when it was confirmed as a joint venture in 2012. Under the terms of the original agreement, Biogen had the right to purchase up to 50% less one share of Samsung Bioepis, which it exercised in June 2018.
The deal is expected to further elevate Samsung Bioepis’ sales growth, marginal improvements, budget surplus, streamlining operational efficiencies, and cash flow generation. Samsung Bioepis has been achieving great wonders with the successful launch of five biosimilars worldwide, two biosimilars for oncology and three for autoimmune diseases. In addition to that, one product is to be released very soon in the market and four more biosimilars are currently in Phase 3 clinical trials. This agreement is supposed to accelerate Samsung Bioepis’ biosimilar research & development and enhance their future performance in novel drug development, with improved autonomy and agility in business operations.
Merck Receives EU Approval For Keytruda in Adjuvant Kidney Cancer
In the latest regulatory update, Merck has announced that the European Commission has approved Keytruda (anti-PD-1 therapy), as monotherapy for the adjuvant treatment of renal cell carcinoma (RCC) in adults with intermediate-high or high risk of recurrence, following nephrectomy, or resection of metastatic lesions.
With this approval, now Keytruda became the first immunotherapy approved as adjuvant therapy for patients with Renal Cell Carcinoma in Europe. The therapy is expected to be marketed in 27 EU member states, including some other countries such as Norway, Iceland, Lichtenstein, and Northern Ireland. In November 2021, Merck got the FDA approval for Keytruda as adjuvant therapy for certain patients with RCC following surgery in the US.
Renal cell carcinoma (RCC) is one of the most types of kidney cancer and accounts for nearly 9 out of 10 kidney cancers. In the Phase III KEYNOTE-564 study, Keytruda is evaluated as adjuvant therapy in 994 patients with intermediate-high or high risk of recurrence of RCC. Keytruda exhibited improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% as compared to placebo.
Keytruda is the key therapy of Merck and has already received approval for several types of cancers by different health authorities globally. Currently, around 1,700+ clinical trials are going on to assess Keytruda for a variety of cancers.
Glenmark Pharma’s Arm Receives Final USFDA Approval For a Blood Pressure Drug
In another regulatory update, the US subsidiary of Glenmark Pharmaceuticals has received the USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide tablets for the treatment of high blood pressure. The hypertension treatment drug that received approval are the generic version of Ziac tablets of Teva Branded Pharmaceutical Products R&D, Inc, with strengths of 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 MG. Over the years, high blood pressure (HBP, or hypertension) has emerged as a “silent killer”, affecting a significant population worldwide. In the US, nearly 1 out of 2 adults has hypertension, and around 1 in 5 adults is recommended lifestyle modifications only. Similarly, prescription medication with lifestyle modifications is also recommended in most cases.
Glenmark Pharmaceuticals has its presence across generics, specialty, and OTC businesses with a major focus on respiratory, dermatology, and oncology segment. Currently, it operates in around 80 countries and is globally ranked as one of the leading companies in the generics and biosimilar market. The company has a portfolio consisting of 172 products authorized for distribution in the US Market and 46 ANDA’s pending approval with the US FDA.
Dupixent Has Been Approved By the CHMP For Use in Young Children With Asthma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has announced a positive opinion suggesting that Dupixent (dupilumab) be approved as an add-on maintenance treatment for children aged 6 to 11 years who have severe asthma with type 2 inflammation characterized by raised blood eosinophils and raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is likely to make a final judgment on the Dupixent application in the following months.
Dupixent is a non-immunosuppressive completely human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Diseases like atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis all have IL-4 and IL-13 as significant and central drivers of type 2 inflammation (CRSwNP).
One of the most common chronic disorders in children is asthma. Type 2 inflammation affects up to 85% of children with asthma, and they are more likely to have a higher illness burden. These children may continue to have significant symptoms such as coughing, wheezing, and trouble breathing despite therapy with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators. Severe asthma can harm a child’s growing airways and lead to possibly fatal exacerbations. Multiple courses of systemic corticosteroids may be required for children with severe asthma, which has significant hazards. Severe asthma that isn’t well-controlled might make it difficult to sleep, go to school, or participate in sports. The FDA authorized Dupixent on October 20, 2021 whereas for the EU evaluation, Dupixent in children aged 6 to 11 years with severe uncontrolled asthma is still under evaluation.
Dupixent is currently approved in Europe for adults and adolescents aged 12 and up as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and increased FeNO. They are uncontrollable with high-dose ICS plus another medicinal product for maintenance treatment. It is also approved for treatment in some people with asthma, select patients with moderate-to-severe atopic dermatitis, and CRSwNP in various age groups in the United States, Japan, and other countries worldwide. Dupixent is also approved in more than 60 countries for one or more of these indications, with more than 350,000 patients treated worldwide.
Voxelotor Has Received Positive Feedback For the Treatment of Hemolytic Anemia
Global Blood Therapeutics, Inc. announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Oxbryta (voxelotor) tablets for the treatment of hemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older, either alone or in combination with hydroxycarbamide (hydroxyurea). Oxbryta, a once-daily oral medication, would be the first in Europe to directly prevent sickle haemoglobin (HbS) polymerization, the molecular cause of sickling and red blood cell death in Sickle Cell Disease.
The European Commission, which allows marketing clearance in the European Union, is likely to make a judgement based on this Committee for Medicinal Products for Human Use recommendation in the first quarter of 2022. Oxbryta will be permitted for marketing in all EU member states, as well as Iceland, Liechtenstein, and Norway, if the EC approves it.
In the United States, Oxbryta is now licenced for the treatment of SCD in adults and children aged 12 and up. 12 GBT is seeking regulatory permission in the United States to expand the possible use of Oxbryta for the treatment of SCD in children as young as four years old. Oxbryta has been given marketing approval in the United Arab Emirates (UAE) by the Ministry of Health and Prevention (MOHAP) for the treatment of SCD in adults and children aged 12 and up.
The CHMP conclusion is based on evidence showing clinically meaningful and statistically significant improvements in haemoglobin (Hb) levels in patients treated with Oxbryta, as well as decreases in red blood cell breakdown (hemolysis). The analysis also revealed that trial participants given Oxbryta experienced numerically fewer vaso-occlusive crises (VOCs), which was consistent with trends at 24 weeks, and were three times less likely to have an acute episode (a fall in Hb >2 g/dL from baseline). Oxbryta treatment was well tolerated, and no new safety or tolerability findings were discovered.