Solid dosage products are a mainstay of new drug development, but parenteral drug development is on the rise. So which product form leads in new drug development? DCAT Value Chain Insights (VCI) examines key trends.

The rise in biologic-based drug development is a contributing factor to the increase in the number of parenteral drugs under development and recently approved new molecular entities (NMEs). With recent highs in the number of NMEs approved in the US in 2015 and 2014, what is the report card on solid dosage and parenteral drugs? DCAT Value Chain Insights (VCI) looks at the number of approvals and drugs approved.;

NME watch: solid dosage versus parenterals
Last year was a banner year for approval of NMEs with 45 NMEs approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research, a recent high. Table I outlines the 45 NMEs approvals in 2015. Of the 45 NMEs approved, 32 were small molecules (new drug applications (NDAs)), one is an insulin analogue approved as a NDA, and 12 are biologics (biologics license applications (BLAs) (see Table I).

The small-molecule approvals in 2015 were: Actelion Pharmaceuticals’ Uptravi (selexipag); Alkmeres’ Aristada (aripiprazole lauroxil); Allergan’s (formerly Actavis) Viberzi (eluxadoline), Avycaz (ceftazidime-avibactam), Kybella (deoxycholic acid), and Vraylar (cariprazine); Amgen’s Corlanor (ivabradine); Asklepion Pharmaceuticals/Retrophin’s Cholbam (cholic acid); Astellas Pharma’s Cresemba (isavuconazonium); AstraZeneca’s Tagrisso (osimertinib) and Zurampic (lesinurad); Bristol-Myers Squibb’s Daklinza (daclatasvir); Daiichi Sankyo’s Savaysa (edoxaban); Eisai’s Lenvima (lenvatinib); Gilead Sciences’ Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Johnson & Johnson’s Yondelis (trabectedin); Merck & Co. ‘s Bridion (sugammadex); Novartis’ Farydak (panobinostat), Odomzo (sonidegib), and Entresto (sacubitril/valsartan); Otsuka Pharmaceutical’s Rexulti (brexpiprazole); Pfizer’s Ibrance (palbociclib); Roche’s Cotellic (cobimetinib) and Alecensa (alectinib); Sprout Pharmaceuticals’ Addyi (flibanserin) (Valeant Pharmaceuticals is acquiring Sprout Pharmaceuticals); Taiho Oncology’s Lonsurf (trifluridine and tipiracil); Tesaro’s Varubi (rolapitant); Takeda Pharmaceuticals’ Ninlaro (ixazomib); The Medicines Company’s Kengreal (cangrelor); Vertex Pharmaceuticals’ Orkambi (lumacaftor and ivacaftor); and Wellstat Therapeutics’ Xuriden (uridine triacetate).

Of these small molecules, seven are parenteral drugs (see Table I).These are: Alkmeres’ Aristada (aripiprazole lauroxil); Allergan’s Avycaz (ceftazidime-avibactam); Allergan’s Kybella (deoxycholic acid); Astellas Pharma’s Cresemba (isavuconazonium) (also delivered in capsule form orally); Johnson & Johnson’s Yondelis (trabectedin); Merck & Co.’s Bridion (sugammadex); and The Medicines Company’s Kengreal (cangrelor);

Twelve biologics were approved in 2015, all delivered parenterally (see Table I). These were: Alexion Pharmaceuticals’ Strensiq (asfotase alfa) and Kanuma (sebelipase alfa); Amgen’s Repatha (evolocumab); Boehringer Ingelheim’s Praxbind (idarucizumab); Bristol-Myers Squibb’s Empliciti (elotuzumab); Eli Lilly’s Portrazza (necitumumab); GlaxoSmithKline’s Nucala (mepolizumab); Johnson & Johnson’s Darzalex (daratumumab); Novartis’ Cosentyx (secukinumab); Sanofi/Regeneron Pharmaceuticals’ Praluent (alirocumab); Shire/NPS Pharmaceuticals’ Natpara (parathyroid hormone); and United Therapeutics’ Unituxin (dinutuximab). Novo Nordisk’s Tresiba (insulin degludec injection), a long-acting basal human insulin analog produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification (it was approved as a NDA and not as a BLA). Also, Astellas Pharma’s Cresemba (isavuconazonium) was approved in two separate dosage forms: capsule form, delivered orally and powder, delivered IV (infusion).

On a comparative basis, 20 NMEs approved in 2015 were parenteral drugs (includes Astella’s Cresemba in parenteral form and Novo Nordisk’s Tresiba) compared with 26 NME solid dosage products (includes Astella’s Cresemba in solid dosage form), keeping solid dosage products as the leading product form with 56% of all NME approvals in 2015. This is up from 2014, when 46% of the NMEs approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research were solid dosage products, but down from 2013, when 63% of the NMEs approved were solid dosage products.