2015 Was The Year of Drug Approvals

It seems that 2015 was the year of drug approvals as the number of newly approved drugs has reached a record high.

The total number of approvals was 51 of which 45 were approved by FDA’s Center for Evaluation and Research and another 6 recombinant therapies were approved by CBER – the Center of Biologics Evaluation and Research.

Four of the treatments approved by CBER are treating blood disorders such as haemophilia, another one is a preventive vaccine for type B meningitis and the last one is a vaccine for melanoma – the deadliest form of skin cancer.

The approved drugs were created by 39 pharmaceutical companies of which eight had multiple drugs approved. For example Novartis has gained five drugs approved and Amgen has gained approvals for three different drugs. The other six companies – Roche; Johnson & Johnson; Bristol-Myers Squibb; Baxalta; Alexion and Actavis – have each gained two approvals.

During the last decade the top 6 Big Pharma leaders have gained approvals for almost 80 new drugs.

The leader seems to be Johnson & Johnson with 17 approvals during the last ten years. GSK and Novartis follow the lead with 15 approvals each. The next comes Pfizer with 11 approvals of which 7 during the past five years.

Coming right after Pfizer, Merck&Co and Roche have gained 10 approvals each. However, if Merck&Co has gained four approvals in the first half of the last decade and the other six during the last five years, Roche has gained 8 of its 10 approvals during the past 5 years.

According to FDA’s database, 31 percent of the drugs approved last year are for cancer. The next domain that has seen improved treatments is rare disease for which 12 percent of the approved drugs have been developed. 10 percent of the drugs are for infectious disease, another 10 percent for blood disorders, 8 percent for cardiovascular diseases and also 8 percent for mental disorders.

In terms of monetary costs, the most expensive drug on the market in 2015 has been Orkambi, developed by Vertex Pharmaceuticals for cystic fibrosis. One-year supply of the drug costs $259.000.

Pfizer has also had one of the most expensive drugs – Ibrance, for treating Breast cancer, which costs $118,200 for one year.

Drugs for more common diseases have also had high prices, such as Daklinza, the drug developed by Bristol-Myers Squibb for hepatitis-C.

The FDA cannot consider the prices of drugs when reviewing the approving requests but many experts argue that this is an important factor which should be considered.

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