Year 2015 should be regarded as a good year for patients worldwide as the US Food and Drug Administration (FDA) has given approvals for 45 New Molecular Entity (NMEs) and New Therapeutic Biological Products (NTBP)s, the most in the past 4-5 years.
In 2014, there were 41 drugs, compared to 27 in 2013 and 39 in 2012.
Majority of the approvals in 2015 are for cancer drugs and biotech-based monoclonal antibodies (mab). Many of them are effective in treating diseases that fail to respond to existing drugs. A look at some of the innovations happened in 2015 gives us an idea on emerging trends and new treatments. While it may take a few more years for these drugs to reach India, it also offers next-generation treatment options to Indian patients in the coming years.
AstraZeneca came up with a new drug Zurampic to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, in combination with a drug approved to reduce the production of uric acid in the body.
San Francisco-based Actelion Pharmaceuticals' Uptravi (selexipag) tablet treats adults with pulmonary arterial hypertension (PAH), a rare chronic lung disease. Genetech's Alecensa (alectinib) is to treat people with advanced non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib) of Pfizer. Eli Lilly's Portrazza (necitumumab), in combination with two forms of chemotherapy, is to treat patients with advanced lung cancers, who have not previously received medication specifically for treating their advanced lung cancer.
Another US company Alexion Pharmaceuticals has come up with Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency, which is also known as Wolman disease. Wolman disease often occurs during infancy (around two to four months of age) and patients with Wolman disease rarely survive beyond the first year of life.
Janssen Biotech's Darzalex (daratumumab) is to treat patients with multiple myeloma who have received at least three prior treatments and this is the first monoclonal antibody approved for treating multiple myeloma.
Another monoclonal antibody, Empliciti (elotuzumab) in combination with two other therapies can treat people with multiple myeloma cancers who have received one to three prior medications. Empliciti is marketed by Bristol-Myers Squibb. Similarly, Japanese company Takeda's NInlaro (ixazomib) in combination with two other therapies can treat people with multiple myeloma who have received at least one prior therapy.
Skin cancer patients also have good news. Greentech's Cotellic (cobimetinib) in combination with vemurafenib can treat advanced melanoma that has spread to other parts of the body or can't be removed by surgery.
Though science has to some extent reined in the dreaded AIDS, new therapies are coming up. Gilead's Genvoya (a fixed-dose combination tablet containing four drugs) is a complete regimen for the treatment of HIV-1 infection in adults and paediatric patients of 12 years and older.
Asthma patients can also breathe easily. GlaxoSmithKline has come up with a new drug Nucala (mepolizumab) for patients who have a history of severe asthma attacks despite receiving their current asthma medicines. US-based Relypsa has come up with a new drug Veltassa that can control high levels of potassium in the body. Insulin specialist Novo Nordisk has brought out Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.
Vertex Pharmaceuticals's new cystic fibrosis drug, Otsuka Pharmaceutical Company's new drug to treat schizophrenia and bipolar disorder, Amgen's Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options, BMS's Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV), Eisai's Lenvima (lenvatinib) to treat patients with thyroid cancer (DTC), and Daiichi Sankyo's anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots etc. will be of interest to numerous Indian patients.