Take stock of new drugs approved by the EU in 2020

Wen: In 2020, in the pharmaceutical industry, the new crown outbreak has led to many clinical trials suspended, new drug approval delayed, drug shortage and many other problems.
difficulties, drug regulators are doing their best to ensure that new drug approvals move forward smoothly.
according to the author's statistics, in 2020 the European Medicines Agency (EMA) approved a total of 41 new active ingredients containing 42 new drug products, see the following summary.
five gene therapy products approved in 2020 were identified as orphan drugs.
of which Orchard Therapeutics' Libmeldy is used to treat hetero-infected brain protein malnutrition.
4, Kite's Tecartus (self-resistant CD19 transducting CD3 plus cells) was approved for the treatment of adult patients with recurring or refractic sleeve lymphoma.
5, Onasemnogeneabeparvovec of Novarma subsidiary AveXis, was approved for the treatment of patients with 5q spinal muscular dystrophy.
9 1, GlaxoSmithKline's orphan drug, Belantamabmafodotin, is the first (first-in-class) humanized anti-BCMA treatment drug, conditionally approved for the treatment of recurring and refractic multiple myeloma.
2, Roche's Rozlytrek( entrectinib), a TRK inhibitor unrelated to tumor type, was conditionally approved for the treatment of solid tumor patients aged 12 years and older with NTRK gene fusion who currently do not have an effective treatment, and for adults with ROS1-positive metastasis non-small cell lung cancer who had not previously been treated with ROS1 inhibitors.
3, Avapritinib, Bueprint Medicnes, a conditionally approved orphan drug for the treatment of adult patients with an indescisive or metastasis gastrointestinal mesothelioma with the PDGFRA D842V mutation.
4, Novart's Piqray (alpelisib) was approved for use with fulvestrant for post-menovascular women and male breast cancer patients who tested positive for hormones (HR plus), human epithelial growth factor 2 negative (HER2-), disease that progressed after a single endocrine therapy, carrying PIK3CA mutations and localized late stage or metastasis.
5, Sanofi's Sarclisa (isatuximab) was approved in a joint treatment with Pomadomin and dexamisson for the treatment of adult patients with recurring and refractic multiple myeloma.
the drug is designed to induce programmed tumor cell death and immunomodulation activity, said Sanofi.
6, Pfizer's orphan drug Daurismo (glasdegib) was approved to be used in combination with low-dose glycosine to treat adult patients with standard-induced chemotherapy for initial diagnosis or secondary acute myeloid leukemia.
7, AstraZenecon's Calabrutinib is used as a monotherapy or in combination with Obinutuzumab to treat adult patients with previously untreated chronic lymphoblastic leukemia (CLL).
as a monotherapy, it is also suitable for adult CLL patients who have received at least one previous treatment.
8, Roche's Polyvy (polatuzumabvedotin), which is conditionly approved as an orphan drug and is used in association with bendamustine and rituximab, is not suitable for adult patients with hematopoietic stem cell transplantation, recurring or refractic large B-cell lymphoma.
9, Bayer's Nubeqa (darolutamide), is used to treat adult male patients with non-metastatic desopathic prostates who are at high risk of developing metastatic diseases.
new vaccine 5 1, Pfizer/BioNTech's COVID-19 vaccine Comernaty, which was eligible for market approval on December 21.
2-3, Jansen's Ebola vaccine, consists of two separate vaccine components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), which each have their own market licenses.
, Vaxchora, a cholera vaccine from Emergent BioSolutions, has been approved for active immunization against diseases caused by Vibrio cholerae serum group O1 in children and adults aged six and over.
5, Sanofi Pasteur's tequi price flu vaccine Supertek (recombined, prepared in a cell medium).
6 infectious disease treatment drugs 1, the TB Alliance's Dovprela (pretomanid) was approved as an orphan drug for the treatment of widely drug-resistant TB (XDR-TB) or multidrative drug-resistant TB (MDR-TB).
2, Elusys Therapeutics' orphan drug, obiltoxaximab (known as Anthim in the United States and Canada), is licensed for use in combination with appropriate antimicrobials for the treatment and post-exposure prevention of inhaled anthrax caused by Bacillus anthrax when alternative therapies are inappropriate or unavailable.
3, the German company MYR GmbH's Hepcludex (bulevirtide), obtained conditional approval of orphan drugs for the treatment of adult patients with HDV-RNA-positive chronic hepatitis viremia plasma (or serum) with reparation liver disease.
4, Nabriva Therapeutics' Xenleta (lefamulin) is used to treat adult CAP patients when it is not considered appropriate to use antimicrobial agents commonly recommended for initial treatment of community-acquired pneumonia (CAP) or when treatment fails.
5, Shionogi's Fetcroja (cephalosporine meldonium sulphate) and Recarbrio (aamine pernam/sicstatin/Rebatan) in Merca East were approved for treatment in adult patients with limited treatment options for infections caused by hypoxic glsine-negative bacteria.
6, ViiV Healthcare's Vocabria (cabotegravir), which treats HIV infection in adults who have received stable antiretroviral treatments and have achieved virological suppression (HIV-1 RNA -lt;50 copy/mL), these patients currently or previously have no evidence of viral resistance, and have no prior virological failure of drugs in the non-nucleoside retrovirase inhibitor and integration enzyme class.
cardiovascular drug 3 1, Novartic's first small interfering RNA (siRNA) cholesterol-lowering drug Leqvio (inclisiran), used to treat adult patients with primary hypercholesterolemia or mixed lipid abnormalities.
2-3, Esperion Therapeutics' two products, Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe), are used in adult patients with primary hypercholesterolemia or mixed lipid abnormalities.
other therapeutic areas 1, Novartic's orphan drug, crizanlizumab, has been granted conditional approval to prevent relapse vascular obstructive distress in patients aged 16 and over with sickle cell disease.
2, Vertex Pharmaceuticals' Kaftrio (elexacaftor/tezacaftor/ivacaftor), the first cystic fibrosis triple therapy for cystic fibers aged 12 and over Patients with an F508del mutation and a minimal functional mutation (F/MF) in the transfilm conductivity regulator (CFTR) gene, or 2 patients with an F508del mutation (F/F).
3, reblozyl (luspatercept) for adult bone marrow proliplative syndrome (MDS) or β transfusion-dependent anemia of thalassemia.
, alnylam's orphan drug Givosiran, is used to treat acute hepatic rickets in adolescents and adults 12 years and older.
5, Recordati SpA's Osilodrostat, an orphan drug adaptation for adults with endo-origin Cushing syndrome.
has also approved nine new drugs for multiple sclerosis: Celgene's Zeposia (ozanimod), for adult patients with relapsed remissive multiple sclerosis, and 2, Novartis' Mayzent (siponimod), for adult patients with secondary multiple sclerosis.
3, Jyseleca (filgotinib) of Gilead/Galapagos, for adult patients with moderate to severe active rheumatoid arthritis who have inadequate or insatiable response to one or more anti-rheumatoid drugs.
Jyseleca can be used as a monotherapy or in combination with methotrexate.
4, Pfizer's Staquis (crisaborole), is used in children and adults 2 years of age and older with mild to moderate endexual dermatitis, and ≤40% of patients are affected by the condition.
5, Novarma's Bolucizumab, is used to treat adult patients with age-related wet macular degeneration.
6, Jazz's Sunosi (solriamfetol), used in adult patients with narcolepsy (accompanied or not accompanied by fainting), and during the day excessive drowsiness (EDS) in adult patients who cannot be satisfied with treatment with primary obstructive sleep apnea therapy (e.g., continuous positive pressure of the gas channel), improves sobriety and reduces EDS.
7, Rigel's Tawlesse (fostamatinib), is used in adult patients with chronic immunodeficiplity that are not effective in other therapies.
8, Alnylam's orphan drug Oxlumo (lumasiran), is used to treat primary type 1 oxalic aciduria of all ages.
9, Hansa Biopharma AB's orphan drug Idefirix (imlifidase) for desensitization treatment for highly sensitive adult kidney transplant patients.
In 2020, when the new crown outbreak becomes the global focus, the review and approval work of the world's mainstream drug regulatory agencies has attracted much attention, and the EMA has ruled out all difficulties and expected that the number of new drugs approved will be higher than in 2019, demonstrating a new level of efficiency in the review of new EMA drugs.