Top 5 pipeline drugs for 2018

New blockbuster drugs to treat HIV, diabetes, cancer, migraine headaches and other conditions are expected to be among the top drugs to hit the marketplace in 2018.

Here are 5 of the top new drugs in the pipeline for 2018, according to analysts.

• An upcoming “HIV triplet” drug (bictegravir/FTC/TAF, Gilead Sciences) will be the biggest potential new drug launch of 2018. In mid-2017, Gilead said that four phase 3 studies evaluating a fixed-dose combination of bictegravir (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (FTC/TAF) to treat HIV-1 met their primary objectives of non-inferiority.

“All indications are that Gilead’s new HIV triplet can reach $5 billion in sales by 2022, based on the strength of their HIV franchise and the company’s willingness to spend resources to remain the market leader as its sales in the hepatitis C market decreases,” John Santilli, president of Access Market Intelligence, told FormularyWatch.

Related: FDA approves first generic Truvada for HIV

Plus, Gilead’s “will be working to aggressively convert patients to these more convenient regimens, especially as other products hit patent expiry,”  Leslie Sandberg Orne, senior partner at Trinity Partners, told FormularyWatch. The manufacturer is expected to price the new triplet therapy aggressively, she added.

     2. Semaglutide (Ozempic, Novo Nordisk), a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, is also expected to produce blockbuster sales. FDA approved the New Drug Application (NDA) for semaglutide injection 0.5 mg or 1 mg in late 2017.

“Novo Nordisk will invest heavily here and this drug is completely in their wheelhouse,” Sandberg Orne said.

Novo Nordisk’s trials have all demonstrated superiority over existing options in blood glucose and weight control, Sandberg Orne said. “In addition, they studied semaglutide against placebo and demonstrated a positive CV effect. With these data, they expect to steal share from existing GLP-1s, and they’ve set their sights on expanding within the diabetes class with their data that the drug is cardio-protective (a feature that other drugs outside the class cannot claim either).”

     3. Apalutamide (ARN-509), for which Johnson & Johnson submitted a New Drug Application to FDA in October, 2017, “will be the first product available for non-metastatic castration-resistant prostate cancer [CRPC) and specifically targets men with rapidly rising PSA (those at highest risk for metastatic disease),” Sandberg Orne said. 

Related: New treatment for advanced kidney cancer approved

Johnson & Johnson has been battling Pfizer for the metastatic prostate cancer market, so ARN-509 would allow Johnson & Johnson to move treatment earlier. “Although they haven’t published the Phase 3 data, they felt confident enough to file with the FDA and early data was strong,” Sandberg Orne said.

     4. Erenumab (Aimovig, Amgen) for migraine headaches is expected to receive FDA approval in 2018. In the fall of 2017, Amgen said that a phase 2 chronic migraine study demonstrated that Aimovig reduced the number of monthly migraine days in patients who have failed previous preventive therapies. In addition, results from a dedicated study in patients with stable angina adds further support to the safety profile of Aimovig, Amgen said.

“The drug has shown to reduce the length of migraine attacks by half and significantly reduce the frequency of attacks,” Santilli said. In addition, Teva and Eli Lilly & Co. (galcanezumab) will likely receive approval for similar migraine therapies in 2018, according to Santilli.

     5. Emicizumab (Hemlibra, Roche), which was approved in late 2017, “fulfills the long-awaited goal of being once-weekly for hemophilia patients,” Sandberg Orne said.

The novel drug is also expected to be extremely profitable, with its estimated $482,000 annual wholesale acquisition cost.

“The product is approved for a subset of the most difficult-to-treat hemophilia patients: those who have inhibitors to standard treatments. Products for these patients command extremely high prices, so we would expect significant sales from this ultra-orphan, high-need population,” Sandberg Orne said.

Read more: FDA approves hemophilia A drug for children