This time last year, the press was bemoaning the state of innovation in the pharmaceutical industry, so it was somewhat of a relief to hear that, in 2018, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved a record-high 59 new molecular entities (NMEs). This surpassed the previous record of 53 NME approvals in 1996, and the 46 approved in 2017. In fact, the 59 NME approvals in 2018 was nearly double the 10-year (2009–2017) average of 33 NME approvals by the FDA’s CDER.

By the end of the first quarter of 2019, the FDA had already approved six NMEs, keeping on track with the six approved in the first quarter of 2018. However, with nine months still to go, we’re all watching to see how Pharma will fare with new product approvals this year.

It was interesting to note that nearly 20 of last year’s 59 new approvals were for indications in the field of oncology, possibly reflecting the FDA’s recent move to introduce less rigorous regulatory procedures for cancer drugs, encouraging an increased rate of innovation in this field. Even more interesting was that several of these approvals were approved for very specific populations, such as Lutathera (Avanced Acelerator Applications) for somatostatin receptor-positive gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs), Tibsovo (Agios Pharmaceuticals) for recurrent acute myeloid leukaemia with a 1DH1 mutation, and Xospata (Astellas) for relapsed or refractory AML with one specific gene mutation.

This could be viewed as an illustration of oncology leading the drive to personalized medicine. Due to the natural heterogeneity of different types of cancer, which can be bio-marked, the field of oncology has seen the most rapid advancement in more precise diagnosis and treatment. As well as enabling healthcare providers to get the right drug to the right patient, ‘biomarker-enabled drug discovery’ is helping to maximize the efficiency of drug development programs. Perhaps the biggest surprise, therefore, is not that there are three such drugs in the FDA’s 2018 approvals list, but that there aren’t more of them. But this could soon be set to change.

A recent ‘pipeline review’ published in The Pharma Letter suggested that industry giants such as Amgen, Gilead and GSK are all maximizing on the potential for biomarker-enabled drug discovery, and there is undoubtedly a strong focus on oncology across the industry, with Roche, Janssen and Merck & Co all showing strong pipelines of late stage candidates. Novartis is also focussing more of its efforts on cell and gene therapies, and the company identifies 26 of its late-stage candidates as “potential blockbusters,” with 60 major regulatory submissions planned between now and 2021. Sanofi’s R&D pipeline is said include 42 NMEs in clinical development, while Pfizer is reported to have as many as 13 wholly-owned or partnered assets in late-stage development.

If these projects reach fruition on schedule, the next couple of years could give us more record breakers for NME approvals at the FDA. These developments all contribute to the growing pharma market, which has been predicted to reach $1.4 trillion (US dollars) by 2020, growing from an estimated value of around $1.1 trillion in 2017. This is good for companies and medical supplies manufacturers within the pharma industry, and also for those that support it, including contract development and manufacturing organizations.

This many be one spot of good news in an otherwise bleak forecast for the world economy this year, which is expected to show a slowdown in growth following a ‘mini-boom’ over the past two years. Aside from regional issues such as Brexit, national interest rates and strong/weak currencies, global trade wars are likely to continue into 2019 – especially between the US and China, with resulting impacts on tariffs, and pressures on those businesses affected.

Reference:

www.thepharmaletter.com/article/the-pharma-letter-s-pipeline-review-2019

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and has more recently taken up the role of Editorial Director at Chemicals Knowledge. She continues to also provide independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.