The pharmaceutical industry is on a record-setting pace for approvals of new molecular entities (NMEs) in 2018. Through early November, the FDA had approved 48 NMEs, already outpacing 2017’s recent high of 46 NME approvals and nearing the high mark of 53 NME approvals set in 1996. So which companies have made the regulatory cut, and what is the mix between small molecules and biologics?

Small molecules are dominating thus far, with 35 small-molecule NME approvals and 13 biologic-based NME approvals. Approximately 40% of the approvals are from the pharmaceutical majors with small to mid-sized companies showing the NME muscle thus far. DCAT Value Chain Insights takes an inside look.

Inside NME approvals thus far in 2018

As of November 1, 2018, The Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) had approved 48 NMEs (see Table I at the end of article), already surpassing the 46 NMEs approved in 2017, which was second only to the 53 NMEs approved in 1996. Although NME approvals do not necessarily follow a chronological track with more than one month remaining in calendar year 2018 and withadditional approvals often made at the end of year, 2018 has the potential to be a record-setting year for NME approvals.

The uptick in NME approvals in 2017 and now again in 2018 resumes an upward trajectory beginning in 2011 (with the exception of 2013 and 2016) for NME approvals with 30 NMEs approved in 2011 and 39 in 2012. The exceptions were in 2013, which had a decline to 27 NMEs, and 2016, which had 22 NME approvals, but levels jumped again to 41 NMEs approved in 2014 and in 2015 when 45 NMEs were approved.

Table I at the end of the article enumerates the NME approvals thus far in 2018. Small molecules are dominating thus far, with 35-small molecule NME approvals and 13 biologic-based NME approvals, which includes one antibody drug conjugate (ADC). This product mix in 2018 is consistent with NME approvals in 2017. The 35 small molecules approved thus far in 2018 represents 73% of NME approvals; in 2017, small-molecule NME approvals accounted for 75% of new drug approvals (see Table II at end of article). Biologic-based drugs have accounted for 17% of NMEs approvals thus far in 2018 compared to 15% for all of 2017.

The large pharmaceutical companies with biologic-based drug approvals thus far in 2018 include: Amgen’s Aimovig (erenumab-aooe), a drug to prevent migraines in adults; AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk), an ADC for treating hairy cell leukemia; Eli Lilly and Company’s Emgality (galcanezumab-gnlm) for the preventive treatment of migraine in adults; Merck & Co.’s and Sun Pharmaceutical’s Ilumya (tildrakizumab) for treating moderate-to-severe plaque psoriasis; and Teva Pharmaceutical Industries’ Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Table I at the end of the article summarizes all biologic and small-molecule NME approvals thus far in 2018.

Big Pharma and NME approvals

Of the 48 NME approvals thus far in 2018, 19, or 40%, were from the pharmaceutical majors (see Table I). Pfizer led all companies with three NME approvals. AstraZeneca, Eli Lilly and Company, Merck & Co., and Shionogi each had two NME approvals. AbbVie, Allergan, Amgen, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson’s Janssen Pharmaceutical, Novartis (through its acquisition of Advanced Accelerator Applications in January 2018), and Teva each had one (see Table I).