45 novel drugs approved by the FDA in 2015

By Márcio Barra


Savaysa, a novel anti-clotting agent made by Tokyo-based Daiichi Sankyo, and the first new molecular entity to be approved by the FDA in 2015

Novel drug approvals in the US reached a new high in 2015, with 45 new medicines containing new molecular entities approved by the Food and Drug Administration, above the 2014 figure of 41, the record held since 1996. Moreover, of the 45 new approved drugs, more than 40% of new approvals were for rare disease therapies.

IMS Health expects this rising trend of approvals to continue in the coming years, with with 225 new drugs expected to receive clearance between 2016 and 2020, compared to 184 for the 2011-2015 period.  Cancer treatments are expected to be the largest category of new drug approvals.

The full list (still under construction) is provided below:

Orphan Drug Designation Active Ingredient Date FDA-approved use on approval date Mechanism of Action Marketing Authorization Holder
Zurampic No lesinurad 12/22/2015 To treat high blood uric acid levels associated with gout when used in combination with a xanthine oxidase inhibitor. Helps the kidney excrete uric acid by inhibiting the function of transporter proteins involved in uric acid re absorption in the kidney. Astrazeneca
Uptravi Yes selexipag 12/22/2015 To treat pulmonary arterial hypertension Relaxes muscles in the walls of blood vessels to dilate (open) blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs. Actelion Pharmaceuticals
Bridion No sugammadex 12/15/2015 To reverse effects of neuromuscular blocking drugs (rocuronium bromide and vecuronium bromide) used during surgery Bounds to sugammadex’s lipophilic core, rendering the molecule unavailable to bind to the acetylcholine receptor at the neuromuscular junction. Merck Sharp and Dohme Corp
Alecensa Yes (alongside Accelerated Regulatory Approval Pathway,  breakthrough therapy designation and priority review status alectinib 12/11/2015 To treat ALK-positive lung cancer Blocks the activity of the ALK protein, which may prevent Non-Small Cell Lung Cancer cells from growing and spreading. Genentech
Kanuma Yes sebelipase alfa 12/8/2015 To treat patients with a rare disease known as lysosomal acid lipase (LAL) deficiency ( also known as Wolman disease and cholesteryl ester storage disease) The drug provides an rhLAL protein that functions in place of the missing, partially active or inactive LAL protein in the patient. Alexion Pharmaceuticals
Empliciti Yes (alongside breakthrough therapy designation and priority review status) elotuzumab 11/30/2015 To treat people with multiple myeloma who have received one to three prior medications Activates the body’s immune system to attack and kill multiple myeloma cells, in combination with another FDA-approved treatment for multiple myeloma called Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid). Bristol-Myers Squibb
Portrazza No necitumumab 11/24/2015 To treat patients with advanced (metastatic) squamous non-small cell lung cancer who have not previously received medication specifically for treating their advanced lung cancer monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous non-small cell lung cancer tumors Eli Lilly
Ninlaro Yes (alongside priority review status) ixazomib 11/20/2015 To treat people with multiple myeloma who have received at least one prior therapy First oral proteasome inhibitor approved, which acts by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive, in combination with Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid) Takeda Pharmaceuticals
Darzalex Yes (alongside breakthrough therapy designation and priority review status) daratumumab 11/16/2015 To treat patients with multiple myeloma who have received at least three prior treatments. Monoclonal antibody that works by helping certain cells in the immune system attack cancer cells. Janssen Biotech
Tagrisso Yes (alongside Accelerated Regulatory Approval Pathway,  breakthrough therapy designation and priority review status osimertinib 11/13/2015 To treat certain patients with non-small cell lung cancer. The drug has a companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that Tagrisso is known to target. Inhibits both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Astrazeneca Pharmaceuticals (Tagrisso)


Roche Molecular Systems (cobas EGFR Mutation Test v2)

Cotellic Yes (alongside priority review status) cobimetinib 11/10/2015 To be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation) Blocking the activity of an enzyme known as MEK, which is part of a larger signaling pathway. Abnormal activity of signaling pathways can lead to cancer. Genentech
Genvoya No a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide 11/5/2015 For use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older The drug contains a new form of tenofovir, which hinders viral reverse transcriptase. Gilead Sciences
Nucala No mepolizumab 11/4/2015 For use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Reduces the levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma. GlaxoSmithKline
Strensiq Yes (alongside breakthrough therapy designation and priority review status asfotase alfa 10/23/2015 To treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP). Replaces tissue-nonspecific alkaline phosphatase enzyme responsible for formation of an essential mineral in normal bone, which has been shown to improve patient outcomes. Alexion Pharmaceuticals
Yondelis Yes trabectedin 10/23/2015 To treat specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery(unresectable) or is advanced (metastatic). Blocks DNA binding of the oncogenic transcription factor FUS-CHOP and reverses the transcriptional program in myxoid liposarcoma. Janssen Biotech
Veltassa No patiromer for oral suspension 10/21/2015 To treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Binds potassium in the gastrointestinal tract, decreasing its absorption Relypsa Inc.
Praxbind No (approved under the accelerated approval program) idarucizumab 10/16/2015 For use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. binding to Dabigatran to neutralize its effect. Boehringer Ingelheim
Aristada No aripiprazole lauroxil 10/6/2015 To treat adults with schizophrenia Alkermes, Inc.
Tresiba and Ryzodeg 70/30  No insulin degludec injection 9/25/2015 To improve blood sugar (glucose) control in adults with diabetes mellitus Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog.  Novo Nordisk
Lonsurf  No trifluridine and tipiracil 9/22/2015 To treat patients with an advanced form of colorectal cancer who are no longer responding to other therapies trifluridine acts as a nucleoside metabolic inhibitor, and tipiracil as a a thymidine phosphorylase inhibitor.  Taiho Oncology
Vraylar  No cariprazine 9/17/2015 To treat schizophrenia and bipolar disorder in adults Acts as a D2 and D3 receptor partial agonist, with high selectivity towards the D3 receptor Manufactured by Forest Laboratories and distributed by Actavis Pharma
Xuriden uridine triacetate 9/4/2015 To treat patients with hereditary orotic aciduria
Varubi rolapitant 9/2/2015 To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis)
Repatha evolocumab 8/27/2015 To treat certain patients with high cholesterol
Addyi flibanserin 8/18/2015 To treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
Daklinza daclatasvir 7/24/2015 To treat chronic hepatitis C virus (HCV) genotype 3 infections
Odomzo sonidegib 7/24/2015 To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
Praluent alirocumab 7/24/2015 To treat certain patients with high cholesterol
Rexulti brexpiprazole 7/10/2015 To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder
Entresto sacubitril/valsartan 7/7/2015 To treat heart failure
Orkambi lumacaftor 200 mg/ivacaftor 125 mg 7/2/2015 To treat cystic fibrosis
Kengreal canegrelor 6/22/2015 To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention
Viberzi eluxadoline 5/27/2015 To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
Kybella deoxycholic acid 4/29/2015 To treat adults with moderate-to-severe fat below the chin, known as submental fat
Corlanor ivabradine 4/15/2015 To reduce hospitalization from worsening heart failure.
Cholbam cholic acid 3/17/2015 To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders
Unituxin dinutuximab 3/10/2015 To treat pediatric patients with high-risk neuroblastoma
isavuconazonium sulfate 3/6/2015 To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections
Avycaz ceftazidime-avibactam 2/25/2015 To treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
Farydak panobinostat 2/23/2015 To treat patients with multiple myeloma
Lenvima lenvatinib 2/13/2015 To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
Ibrance palbociclib 2/3/2015 To treat advanced (metastatic) breast cancer
Natpara parathyroid horomone 1/23/2015 To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism
Cosentyx secukinumab 1/21/2015 To treat adults with moderate-to-severe plaque psoriasis
Savaysa edoxaban  1/8/2015 To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem



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