A recent article published by the well-known medical and health information website Xconomy pointed out that many new drugs are expected to be approved to enter the market before the end of this year, including new drugs from Sanofi, Pfizer, and Bristol-Myers Squibb. The following are the 12 most noteworthy new drugs that are expected to be approved for marketing in the fourth quarter of 2020:
Inmazeb has been approved by the FDA on October 15 ahead of schedule. It also known as REGN-EB3, was developed by Regeneron Pharmaceuticals using its “rapid response” VelocImmune platform and associated VelociSuite technologies. The specific indication for Inmazeb is infection caused by the Zaire Ebola virus. This drug is the first Ebola treatment drug approved for marketing in the United States. The drug can be used for adults and children with infections, including newborns whose mothers have tested positive for the infection.
SPN-812 was developed by Supernus Pharmaceuticals and its indication is attention deficit hyperactivity disorder (ADHD). It is a viloxazine hydrochloride and a new type of non-stimulating treatment for children and adolescents with ADHD. Serotonin-norepinephrine modulator (SNMA) can inhibit the noradrenergic reuptake transporter and has been approved for the treatment of depression in Europe for many years. If this drug is approved by the FDA, SPN-812 will become the first new treatment for ADHD in ten years.
Sutimlimab is indicated for cold agglutinin disease (autoimmune hemolytic anemia). Sutimlimab was developed by Sanofi, and its biological product licensing application (BLA) is undergoing priority review by the FDA. Sutimlimab is a monoclonal antibody that can target the intrinsic cause of CAD hemolysis by selectively inhibiting complement C1s in the classical complement pathway of the immune system. If this drug is approved, it will be the first and only drug to treat CAD hemolysis. Globally, the incidence of CAD is approximately 16 parts per million. It is estimated that there are 12,000 CAD patients in the United States, Europe, and Japan, and there are about 5,000 CAD patients in the United States alone. Previously, sutimlimab has been granted orphan drug designation and breakthrough therapy designation for the treatment of CAD.
Margetuximab is indicated for breast cancer, developed by MacroGenics. This is an immuno-enhancing monoclonal antibody targeting the Fc domain of human epidermal growth factor receptor 2 (HER2). It has been granted Fast Track designation by the FDA for the treatment of metastatic or locally advanced HER2-positive breast cancer patients who have previously received anti-HER2 targeted therapy. If approved, margetuximab will provide an alternative treatment for patients with HER2-positive metastatic breast cancer.
Lisocabtagene maraleucel (liso-cel)
The indication of liso-cel is diffuse large B-cell lymphoma (DLBCL). liso-cel was developed by Bristol-Myers Squibb (BMS) and may be approved by the FDA in mid-November. It is expected to be marketed under the trade name Breyanzi. The drug will compete with Gilead Sciences’ Yescarta and Novartis’ Kymriah. Liso-cel is an autologous, CD19-directed, chimeric antigen receptor (CAR) T cell therapy consisting of purified CD8+ and CD4+ T cells in a specific ratio (1:1).
Eysuvis is indicated for dry eye, developed by Kala Pharmaceutical Company. This medicine is an ophthalmic solution of loteprednol etabonate, which is used for short-term treatment of the symptoms of dry eye. Currently, Eysuvis is considered suitable for short-term treatment of dry eye rather than maintenance treatment. Since Novartis’ Xiidra (lifitegrast) and Allergan’s Restasis (cyclosporine ophthalmic emulsion) are both used as long-term treatments, this will make Eysuvis uniquely differentiated in this competitive range of indications.
Zokinvy was developed by Eiger and is currently undergoing priority review by the FDA for the treatment of Progeria (also known as Hutchinson-Guilford Progeria Syndrome, HGPS) and Progeroid Laminopathies. If approved, Zokinvy will become the world’s first drug to treat progeria. In December last year, a rolling submission of a NDA has been initiated for Zokinvy, and which was completed in March this year. Prior to this, Zokinvy has been granted Orphan Drug Designation (ODD), Breakthrough Drug Designation (BTD) and Rare Pediatric Disease Designation (RPDD) by the FDA.
Lumasiran is indicated for hyperoxaluria, developed by Alnylam, and is currently undergoing priority review by the FDA. If approved, the drug will become the first therapy to treat ultra-rare pathogenic hyperoxaluria type 1 (PH1), and it will also become the third approved RNAi therapy after the company’s drug patisiran achieved groundbreaking success in 2018. PH1 is characterized by excessive production of oxalic acid in the liver, which causes oxalic acid to accumulate in the kidneys, and renal function gradually declines, usually leading to renal failure. Lumasiran is a subcutaneous RNAi drug targeting hydroxy acid oxidase 1 (HAO1), which encodes glycolate oxidase (GO). Lumasiran suppresses and normalizes the production of oxalate in the liver by silencing HAO1 and consuming GO enzymes, thereby potentially preventing the progression of PH1 disease.
Danyelza is indicated for neuroendocrine tumors, developed by Y-mAbs Therapeutics using its proprietary MULIT TAG protein platform. Danyelza is a humanized 3F8 monoclonal antibody targeting the GD2 antigen. In November last year, the FDA accepted Danyelza’s rolling BLA application for the treatment of relapsed/refractory high-risk neuroblastoma. If approved, Danyelza will become the first new therapy for neuroblastoma since Roche’s Avastin (bevacizumab) was approved in 2009, and the first commercial product of Y-mAbs.
Tanezumab is indicated for osteoarthritis and osteoarthritis pain, jointly developed by Pfizer and Eli Lilly. This is a new type of non-opioid pain reliever and is expected to receive the FDA’s review results in December. The clinical data of the drug is decidedly mixed, making its market road full of uncertainty. However, after discussing with the FDA, the agency stated that it can accept low-dose tanezumab (2.5mg dose) of BLA for the treatment of chronic pain caused by moderate to severe osteoarthritis (OA), and the drug can be used by patients who have taken other painkillers but have insufficient pain relief. Tanezumab is classified as a nerve growth factor (NGF) inhibitor. It is a humanized IgG2 monoclonal antibody that can selectively target binding and inhibit NGF. By selectively inhibiting NGF, tanezumab prevents pain signals generated by muscles, skin or organs from reaching the spinal cord and brain.
Vibegron is indicated for overactive bladder (OAB), developed by Urovant Sciences. Vibegron was originally developed by Merck, which is a selective beta-3 adrenergic receptor agonist for the treatment of patients with overactive bladder (including urge incontinence, urgency, and frequent urination). β-3 adrenergic receptor is the most common subtype on smooth muscle around the bladder, and its selective activation can increase bladder capacity and reduce OAB symptoms. In 2017, Urovant has licensed the vibegron global rights except Japan and some Asian regions. After Merck, Kyorin Pharmaceuticals, and Kissei Pharmaceuticals reached an agreement, the product was launched in Japan in 2018 under the brand name Beova. In December 2019, Urovant submitted an NDA for vibegron at a dose of 75 mg once a day to the FDA. In the US market, vibegron’ s main competitor will be Astellas’ β-3 adrenergic receptor agonist Myrbetriq (mirabegron), which has been on the market in the US since 2012.
ALKS 3831 is indicated for schizophrenia and type I bipolar disorder. ALKS3831 was developed by Alkermes. It is a double-layered tablet made from a new molecular entity samidorphan (a new selective μ-opioid receptor antagonist) and the marketed antipsychotic drug olanzapine. The drug is currently being reviewed by the FDA. Weight gain and clinically related metabolic problems are common side effects of atypical anti-schizophrenics. Olanzapine is an effective antipsychotic drug, but its clinical use is limited by its high incidence of weight gain. ALKD3831 aims to provide olanzapine’s powerful antipsychotic effects while reducing the side effects on body weight and metabolism, thereby improving the safety of treatment.