Medicines-2010
Drugs that saw the world in 2010
Evgenia Lukyanchuk, "Weekly Pharmacy" No. 2-2011
At the beginning of the new year, it has already become a good tradition to summarize the past. The following are the main data on the activities of pharmaceutical companies in the field of creating new drugs and approving them by regulatory authorities, in particular the US Food and Drug Administration (FDA).
In general, the past year has been favorable for pharmaceutical companies. But in 2010 The FDA has not set new records for the number of approved drugs. According to data published on the FierceBiotech website, only 21 new medicines were approved last year – less than in 2009 and 2008, when 25 and 24 drugs were approved, respectively. Nevertheless, 2010 was more successful for the field of registration of medicines than, for example, 2007, when only 18 drugs were approved.
6 biological and 15 low-molecular-weight medicines have successfully passed the control of regulatory authorities. The FDA is constantly tightening data reliability controls and introducing new warnings for the use of already marketed drugs. In 2010, no company was able to pass through the regulatory authorities several drugs, unlike in 2009, when some pharmaceutical companies managed to register more than one drug.
So, below is a list of medicines approved by the FDA in 2010.
Actemra™/Actemra (tocilizumab, Roche Holding AG) – the first drug based on monoclonal antibodies that inhibit interleukin-6 receptors, which is used to treat rheumatoid arthritis. The drug is approved for the treatment of severe rheumatoid arthritis in patients who are not sensitive to therapy directed against tumor necrosis factor.
Ampyra™ (dalfampridine, Acorda Therapeutics Inc.) – it is used for the treatment of multiple sclerosis, helps to improve the coordination of movements when walking. The approval of this drug has caused increased investor interest in this company.
Asclera® (polydocanol, "Chemische Fabrik Kreussler&Co.") is a low–molecular-weight drug intended for the treatment of varicose veins. It affects the walls of vessels whose diameter does not exceed 3 mm, and contributes to their narrowing.
Carbaglu® (cargluminic acid, "Orphan Europe") – is used with a lack of N-acetylglutamate synthase, leading to the accumulation of ammonia in the blood and other metabolic disorders. This low-molecular-weight drug is an activator of 1-carbamoyl phosphate synthetase.
Egrifta™ (thesamorelin, "Theratechnologies Inc.") – it is used for the treatment of lipodystrophy along with antiretroviral therapy for infection of forks. Lipodystrophy is a local lesion of adipose tissue. The active substance of the drug is somatotropin-releasing factor.
ella™ (ulipristal, "HRA Pharma"/"Watson Pharmaceuticals Inc.") – used for emergency contraception. The new drug has become an improved version of the previous one, now the drug makes it possible to prevent pregnancy within 5 days instead of 3 after unprotected sexual intercourse.
Gilenya™ (fingolimod, Novartis International AG) – the first drug against multiple sclerosis in tablet form. The company expects that its annual sales volume will amount to 3.5 billion US dollars. Gilenya's competitor may be another immunomodulator for internal use, Cladribine (cladribine, Merck KGaA), the application for approval of which will be considered in February this year.
Halaven™ (eribulina mesilat, "Eisai Co.") – used for the treatment of breast cancer as a third-line therapy after two types of chemotherapy. The composition of the drug includes a microtubule collection inhibitor – a synthetic version of a substance found in marine sponges.
Jevtana® (cabazitaxel, "sanofi-aventis S.A.") is a low–molecular-weight drug used for the treatment of prostate cancer. The FDA has approved as a second-line therapy for metastatic hormone-resistant prostate cancer. The drug is used in combination with prednisone after patients undergo chemotherapy using Taxotere™/Taxotere™ (docetaxel, "sanofi-aventis S.A.").
Krystexxa™ (pegloticase, Savient Pharmaceuticals Inc.) – a medicine for the treatment of gout. The FDA rejected applications for the drug for a year, but it was approved in September 2010.
Lastacaft™ (ophthalmic solution of alkaphtadine, Johnson&Johnson Services Inc./Allergan Inc.) – used to treat conjunctivitis, eliminates itching and redness of the eyes.
Latuda® (lurazidone hydrochloride, "Dainippon Sumitomo Pharma Co. Ltd.") is used for the treatment of schizophrenia. This drug, like other atypical antipsychotic drugs, is not permissible to use for the treatment of psychoses that have developed against the background of dementia.
Lumizyme™ (alglucosidase alpha, "Genzyme Corp.") – indicated for the treatment of type II glycogenosis, which develops due to gene mutation and leads to cardiac, respiratory and muscle failure, as a result of which respiratory arrest and death may occur. Lumizyme promotes the displacement of acid from the active center of the enzyme alpha-glucosidase and thus reduces the amount of glycogen in the heart muscle and skeletal muscles. The drug can cause anaphylactic shock, a variety of allergic and immune reactions.
Natazia® (estradiol + dienogest, "Bayer AG") – oral contraceptive, which includes estrogen and progestin in four different dosages depending on the day of the menstrual cycle.
Pradaxa® (dabigatran etexilate, "Boehringer Ingelheim GmbH") is intended for the treatment of atrial fibrillation. According to experts, the revenue from sales of Pradaxa may amount to $ 1.3 billion per year, but the drug may face serious competition when Xarelto®/Xarelto® (rivaroxaban, Johnson & Johnson) and apixaban (Bristol-Myers Squibb Co./Pfizer Inc.) are approved.
Prolia™ (denozumab, "Amgen Inc.") – a biological drug that is used to treat osteoporosis in postmenopausal women.
Teflaro™ (ceftaroline fosamil, Forest Laboratories Inc.) – an antibiotic related to cephalosporins is used to treat intrahospital and drug-induced bacterial pneumonia and acute bacterial infections of the skin, including cases caused by methicillin-resistant Staphylococcus aureus.
Victoza® /Victoza® (liraglutide, Novo Nordisk A/S) – designed to improve traditional therapy for type II diabetes mellitus. The drug keeps the blood glucose level at an acceptable level, preventing it from falling below the norm, and also stimulates a decrease in body weight in patients. According to the results obtained in animal studies, taking this drug increases the risk of developing malignant neoplasms, in particular thyroid cancer. Despite these data, experts predict that sales of the drug will reach $ 1.33 billion. per year.
Vpriv™ (velaglucerase alpha, "Shire Pharmaceuticals plc.") – it is used to treat a rare hereditary disease – Gaucher's disease. The cost of the drug is 170 thousand. USD, which is 15% less than its competitor Cerezyme™ (imiglucerase, Genzyme Corp.), as a result of which Genzyme risks losing a significant part of the market.
Xeomin® (incobotulinum toxin A, "Merz Pharma Group") is a biological drug based on botulinum toxin, which is indicated for the treatment of blepharospasm and idiopathic cervical dystonia. According to the company, since 2005, about 84 thousand patients have taken the drug.
Xiaflex™ (clostridium collagenase, Auxilium Pharmaceuticals Inc.) is indicated for the treatment of Dupuytren's contracture – an overgrowth of the connective tissue of the palm, which leads to involuntary clenching of the fingers into a fist, and over time the patient loses his ability to work. According to various estimates, this disease has been diagnosed in 7-14 million people.
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20.01.2011