Key FDA Approved Drugs in 2016

01 Mar Key FDA Approved Drugs in 2016

While President Trump believes that  ‘slow and burdensome’  FDA drug approval process is ‘keeping too many new drugs from reaching the market’, former FDA Director Rob Califf differs in his opinion when he says that ‘Drug regulation drives innovation’.

Rob Califf, a cardiologist goes on to elaborate, (in Forbes), that the drug development and approval process being followed is to save situations like that of birth defects caused by thalidomide. In order to approve a drug, the FDA has to assure that the drug/medical device is completely safe for use by humans. The safety and efficacy terms and conditions enforced by the FDA for drug approval forces pharmaceutical companies to bring in innovation as well as  improvements to existing therapies.

Let us take a look at the current FDA approval process:

It takes 12 years on an average and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.

If the FDA gives the green light, the “investigative” drug will then enter three phases of clinical trials:

  • Phase 1 uses 20-80 healthy volunteers to establish a drug’s safety and profile. (about 1 year)
  • Phase 2 employs 100-300 patient volunteers to assess the drug’s effectiveness. (about 2 years)
  • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

 

The company then submits an application to the FDA for approval, a process that can take up to two and a half years. The FDA reviews a standard drug application within 12 months and a priority application within 6 months. Application for drugs similar to those on the market are considered standard, whereas priority applications represent drugs offering important advances in addition to existing treatments. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.

The year 2016 turned out to be a disappointing one for NEW drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale. The annual report from the FDA’s Office of New Drugs provides some insights into the sharp drop-off. ( “new” drug approvals refer to new therapies, and wouldn’t include, for example, an existing cancer drug that was already approved to treat melanoma and then gained an additional indication to treat lung cancer.)

Here is a look at the  drugs approved by the FDA in 2016

Cardiology/Vascular Diseases

 

Dermatology

 

Endocrinology

 

Family Medicine

 

Gastroenterology

  • Zinplava (bezlotoxumab); Merck; For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment, Approved October 2016

 

Genetic Disease

 

Hematology

 

Hepatology (Liver, Pancreatic, Gall Bladder)

 

Immunology

 

Infections and Infectious Diseases

 

Musculoskeletal

  • Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016
  • Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016
  • Zinbryta (daclizumab) ; Biogen; For the treatment of relapsing multiple sclerosis, Approved May 2016

 

Nephrology

  • Cabometyx (cabozantinib); Exelixis; For the treatment of advanced renal cell carcinoma, Approved April 2016
  • Lenvima (lenvatinib); Eisai; For the treatment of advanced renal cell carcinoma, Approved May 2016
  • Rayaldee (calcifediol) ; Opko Health; For the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, Approved June 2016

 

Neurology

 

Obstetrics/Gynecology (Women’s Health)

  • Intrarosa (prasterone vaginal insert); Endoceutics; For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause, Approved November 2016
  • Rubraca (rucaparib); Clovis Oncology; For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation, Approved December 2016

 

Oncology

  • Cabometyx (cabozantinib); Exelixis; For the treatment of advanced renal cell carcinoma, Approved April 2016
  • Keytruda (pembrolizumab); Merck; For the treatment of head and neck squamous cell cancer , Approved August 2016
  • Lartruvo (olaratumab) ; Eli Lilly; For the treatment of soft tissue sarcoma, Approved October 2016
  • Lenvima (lenvatinib); Eisai; For the treatment of advanced renal cell carcinoma, Approved May 2016
  • Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of classical Hodgkin lymphoma, Approved May 2016
  • Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck, Approved November 2016
  • Rubraca (rucaparib); Clovis Oncology; For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation, Approved December 2016
  • Sustol (granisetron); Heron Therapeutics; For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016
  • Syndros (dronabinol oral solution); Insys Therapeutics; For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016
  • Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016
  • Venclexta (venetoclax); AbbVie; For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016

 

Ophthalmology

 

Pediatrics/Neonatology

 

Pharmacology/Toxicology

  • Sustol (granisetron); Heron Therapeutics; For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016

 

Psychiatry/Psychology

  • Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016

 

Pulmonary/Respiratory Diseases

 

Urology

  • Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016

 

Vaccines

  • Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016

 

According to Vox, ‘the FDA is the fastest drug regulatory agency in the world’. The FDA also has many exceptions where drugs can be approved fairly faster like accelerated approvals, orphan drugs, priority preview and fast track.

However, whether relaxing the drug approval process will provide improved treatment options for patients remain to be seen.

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