FDA Approves Luye Pharma’s Rykindo for Schizophrenia

Luye Pharma has received its first FDA approval for Rykindo, an injectable formulation of the antipsychotic risperidone administered every two weeks. Rykindo has been approved by the US Food and Drug Administration for the treatment of schizophrenia as well as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

The bi-weekly intramuscular shot, which was also approved in China in 2021, will enter a crowded market for long-acting injectable (LAI) schizophrenia therapies in the United States, where it will face stiff competition from drugs that require less frequent dosing. This includes Johnson & Johnson’s blockbuster Invega (paliperidone) line, which includes once-monthly (Invega Sustenna), three-monthly (Invega Trinza), and six-monthly (Invega Hafyera) versions, as well as other top sellers such as Lundbeck’s Abilify Maintena (aripiprazole).

However, Rykindo is a trailblazer product for Luye Pharma, allowing the Chinese company to establish a commercial presence in the US antipsychotics market as it develops its own pipeline of longer-acting candidates for schizophrenia and bipolar disorder. Luye’s injectables are built on a proprietary microsphere technology platform that regulates active drug release, extending its half-life in the body.

They include LY03010, a once-monthly paliperidone with comparable bioavailability to Johnson & Johnson’s Invega Sustenna in a pivotal trial, and a slightly simpler regimen in the induction therapy stage. It will have a long road ahead of it to catch up to the USD 1 billion in quarterly revenue currently recorded by J&J’s Invega franchise.

EU Approves AstraZeneca’s Severe Asthma Drug Tezspire

Tezspire, AstraZeneca’s first-in-class severe asthma therapy, has been approved in the EU in a new pen injector formulation suitable for patient administration. Tezspire (tezepelumab) pre-filled, single-use pen approval comes just four months after the TSLP inhibitor became the first biologic therapy for severe asthma to be cleared in the EU for use in all patients, rather than those with forms of the disease associated with specific characteristics such as high levels of eosinophils.

Mene Pangalos, AstraZeneca’s head of biopharma R&D, stated that the new device would help support the use of Tezspire to treat “a large population of severe asthma patients.” It is estimated that there are 2.5 million severe asthma patients worldwide who are uncontrolled, with no phenotypic or biomarker limitations. The biologic is currently delivered as a pre-filled syringe that is dosed once a month by a healthcare worker, but the new formulation will give patients more control over their treatment. It is approved in the EU, like its predecessor, for use in patients 12 years of age and older with severe asthma who are not adequately controlled with high-dose inhaled corticosteroids plus another medicinal product.

The new formulation was approved based on the findings of the phase I PATH-BRIDGE and phase III PATH-HOME studies, which revealed that 92% of healthcare providers, patients, and caregivers were able to successfully administer it, with no loss of efficacy when compared to the approved formulation. The European Union approved the pen injector before the United States, where AstraZeneca’s partner Amgen has been selling Tezspire since the beginning of 2022. In the United States, Amgen reported USD 55 million in sales in the third quarter of 2022, bringing its total for the first nine months to USD 91 million.

Oramed Announces Results from Phase 3 Trial of ORMD-0801 for the Treatment of Type 2 Diabetes

On Jan. 11, 2023, Oramed Pharmaceuticals Inc. announced top-line results from its Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks. Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company’s novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption.

The trial enrolled 710 Type 2 Diabetes patients with inadequate glycemic control on two or three oral glucose-lowering agents. The ORA-D-013-1 trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks. 

In the ORA-D-013-1 trial, patients were randomized 2:2:1:1 into four groups: 8 mg dosed once daily; 8 mg dosed twice daily; placebo dosed once daily, and placebo dosed twice daily. Patients completed an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period. 

After the results from the Phase 3 Trial of ORMD-0801, Nadav Kidron, Oramed’s Chief Executive Officer, stated, “Today’s outcome is very disappointing, given the positive results from prior trials. Once full data from the studies are available, we expect to share relevant learnings and future plans. We thank all the patients, families, and healthcare professionals who participated in the trial.”

The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks. There were no serious drug-related adverse events. Moreover, as per the update from Oramed, the company expects to discontinue its oral insulin clinical activities for Type 2 Diabetes.

After FDA Approval, Eisai and Biogen File Lecanemab in the EU

On January 10, 2023, Eisai Co., Ltd. announced today that Eisai had submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™) to the European Medicines Agency (EMA). Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s Disease (AD) and mild AD dementia).

Eisai and Biogen jointly worked to develop and market the lecanemab. Eisai serves as the lead of lecanemab development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Eisai and Biogen’s marketing authorization application is based on the results of the Phase III Clarity Alzheimer’s Disease study and the Phase IIb clinical study (Study 201), which showed that lecanemab treatment exhibited a reduction of clinical decline in early Alzheimer’s Disease and is subject to validation to determine whether the EMA accepts the application for review. 

The Clarity Alzheimer’s Disease study met its primary endpoint (CDR-SB1: Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Earlier in November 2022, the Clarity Alzheimer’s Disease study result was presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journal. On  January 6, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to lecanemab as a treatment for Alzheimer’s Disease in the United States. Moreover, the Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated the submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai’s fiscal year 2022, which ends March 31, 2023. Alzheimer’s disease is a complex neurological issue and affects a significant proportion of the population globally. As per the estimate, in Europe, about 9.5 million people have suffered from Alzheimer’s disease and other forms of dementia. The approval and launch of the lecanemab is anticipated to immensely transform early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) in the EU region. 

AbbVie and Anima Biotech Announce Collaboration Worth Over USD 580 Million

AbbVie and Anima Biotech declared a collaboration to discover and develop mRNA biology modulators for three targets across therapeutic areas, Oncology and Immunology. Anima will utilize its mRNA Lightning platform to find novel mRNA biology modulators against the collaboration targets, providing AbbVie exclusive rights to license and further commercialize the programs.

Vice President & global head of discovery research at AbbVie, Jonathon Sedgwick, Ph.D., stated: “AbbVie will have access to Anima’s cutting-edge technology platform and in-depth knowledge of mRNA biology through this collaboration, which will also help to further strengthen AbbVie’s world-class capabilities in discovering and developing drugs to improve the lives of patients. A novel strategy that could potentially address ‘undruggable’ targets and have implications for numerous therapeutic fields is the modification of mRNA biology with small molecules.

In accordance with the terms of the contract, Anima will pay a $42 million upfront fee and may be qualified to receive up to $540 million in option fees, research and development milestones, and commercial milestones, as well as the possibility of additional commercial milestones and tiered royalties on net sales. The agreement can be extended to up to three more targets by AbbVie under the same conditions as the original collaboration, which could raise the partnership’s potential value.

AstraZeneca’s Avillion Receives FDA Approval for Asthma 

The US Food and Drug Administration approved AstraZeneca and Avillion’s Airsupra to treat asthma.

Previously known as PT027, Airsupra is a pressurized metered-dose inhaler, fixed-dose combination rescue medication. It comprises short-acting beta2-agonist albuterol and anti-inflammatory inhaled corticosteroid budesonide.

Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above.

It is claimed to be the country’s first and only rescue medication approved for this indication. AstraZeneca and Avillion are developing the drug under a co-development agreement signed in March 2018.

The data from the Phase III MANDALA and DENALI studies were the foundation for the regulatory approval.

In the MANDALA trial, individuals with moderate to severe asthma who took Airsupra had a considerably lower risk of severe aggravations than those who took albuterol.

It also significantly reduced mean annualized total systemic corticosteroid exposure compared to the trial’s secondary endpoint of albuterol.

The treatment significantly improved lung function in patients with mild to moderate asthma in the DENALI trial compared to albuterol and budesonide alone. Additionally, it showed consistent safety and acceptability in both trials with the known profiles of the components.