Pharmaceutical companies are emerging from the innovation crisis
Innovations in the development of medicines and biological products according to the results of 2012
Julia Gitsman, "Weekly Pharmacy" www.apteka.ua based on the materials of the FDA, Forbes and NASDAQInnovation drives progress.
The US Food and Drug Administration (FDA) summed up the results of fiscal 2012, which indicates that pharmaceutical companies are emerging from the crisis of innovation, and the emergence of innovative medicines means new opportunities for the treatment of patients and, as a result, progress in the field of healthcare. Readers will be able to learn about which medicines have been approved by the FDA from this publication.
The FDA approved 31 new medicines in fiscal 2012 (table), which ended in September of this year. That is, as much as in the same period last year, which has become one of the best results over the past decade. For example, 21 were approved for calendar year 2009, in 2010. – 26 drugs.
FDA-approved drugs based on the results of 2012№
| Name of the drug | Active substance | Date | Indications for use | 1. |
| Voraxaze | glucarpidase | 17.01.12 | For the treatment of patients with toxic levels of methotrexate in the blood due to renal insufficiency | |
| 2. | Picato | ingenol mebutate | 23.01.12 | For local treatment of senile keratosis |
| 3. | Inlyta | axitinib | 27.01.12 | For the treatment of patients with late-stage kidney cancer (renal cell carcinoma) |
| 4. | Erivedge | vismodegib | 30.01.12 | For the treatment of adult patients with basal cell skin cancer |
| 5. | Kalydeco | ivacaftor | 31.01.12 | For the treatment of cystic fibrosis in adults and children over the age of 6 years |
| 6. | Zioptan | tafluprost | 10.02.12 | To reduce increased intraocular pressure in patients with glaucoma or ocular hypertension |
| 7. | Surfaxin | lucinactant | 06.03.12 | For the treatment and prevention of respiratory distress syndrome in premature infants whose lungs are not yet fully developed |
| 8. | Omontys | peginesatide | 27.03.12 | For the treatment of anemia, a condition in which not enough healthy red blood cells are produced |
| 9. | Amyvid | florbetapir F 18 | 06.04.12 | It is used as a radioactive diagnostic tool for positron emission tomography of the brain to assess the number of plaques in the brain of a patient with signs of Alzheimer's disease or dementia for other reasons |
| 10. | Stendra | avanafil | 27.04.12 | For the treatment of erectile dysfunction |
| 11. | Elelyso | taliglucerase alfa | 01.05.12 | It is used as an enzyme replacement in people with type I Gaucher disease (a rare genetic disease) |
| 12. | Perjeta | pertuzumab | 08.06.12 | For the treatment of breast cancer patients with metastases to other organs |
| 13. | Belviq | lorcaserin hydrochloride | 27.06.12 | To reduce excess body weight, possibly associated with diabetes, high cholesterol or high blood pressure |
| 14. | Myrbetriq | mirabegron | 28.06.12 | For the treatment of adults with overactive bladder |
| 15. | Prepopik | sodium picosulfate, magnesium oxide and citric acid | 17.07.12 | For colon cleansing in adults, preparation for colonoscopy |
| 16. | Kyprolis | carfilzomib | 20.07.12 | For the treatment of patients with multiple myeloma who have already received several courses of treatment |
| 17. | Tudorza Pressair | aclidinium bromide | 23.07.12 | For long-term supportive treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema |
| 18. | Zaltrap | ziv-aflibercept | 03.08.12 | It is used in combination with other drugs for the treatment of colorectal cancer |
| 19. | Stribild | elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate | 27.08.12 | For use without other antiretroviral drugs in HIV-1 in adults who have never previously taken medications for this disease |
| 20. | Neutroval | tbo-filgrastim | 29.08.12 | To reduce the duration of severe neutropenia and the frequency of febrile neutropenia in patients after cancer chemotherapy |
| 21. | Linzess | linaclotide | 30.08.12 | For the treatment of chronic idiopathic constipation and for the treatment of irritable bowel syndrome with constipation in adults |
| 22. | Xtandi | enzalutamide | 31.08.12 | For the treatment of men with late-stage prostate cancer |
| 23. | Bosulif | bosutinib | 04.09.12 | For the treatment of chronic myeloid leukemia, blood and bone marrow diseases |
| 24. | Aubagio | teriflunomide | 12.09.12 | For the treatment of adults with recurrent multiple sclerosis |
| 25. | Choline C 11 Injection | choline C 11 Injection | 12.09.12 | It is used in positron emission tomography to detect recurrence of prostate cancer |
| 26. | Stivarga | regorafenib | 27.09.12 | For the treatment of patients with colorectal cancer that has progressed after treatment, with metastases to other organs |
| 27. | Jetrea | ocriplasmin | 18.10.12 | For the treatment of symptomatic adhesion |
| 28. | Fycompa | perampanel | 22.10.12 | For the treatment of patients with epilepsy attacks aged 12 years and older |
| 29. | Synribo | omacetaxine mepesuccinate | 26.10.12 | For the treatment of adult patients with chronic myeloid leukemia, blood and bone marrow diseases |
| 30. | Xeljanz | tofacitinib | 06.11.12 | For the treatment of patients with rheumatoid arthritis |
| 31. | Cometriq | cabozantinib | 29.11.12 | For the treatment of medullary thyroid cancer with metastases to other organs |
These medicines are innovative, that is, those that have never been used in clinical practice before.
Among the approved drugs, both new active substances and already known combinations of medicines modified with the introduction of innovative active substances are presented.
This year, for the first time, drugs for the treatment of cystic fibrosis (Vertex Pharmaceuticals), a drug for the treatment of targeted basal cell skin cancer (Roche), as well as new combinations of drugs for the treatment of HIV infection (Gilead Pharmaceuticals) were approved.
The FDA approval process for innovative drugs is much faster than in other countries, in accordance with the deadlines established by law.
75% of all new drugs approved in other countries were first approved in the United States. The mandatory availability of complete information on clinical trials of medicines made it possible for the FDA to approve about 77% of drugs without reconsideration.
Portal "Eternal youth" http://vechnayamolodost.ru13.12.2012