Novo Nordisk’s Rybelsus approval marks the arrival of pharma’s latest major launch, but it’ll soon be joined on the market by other blockbusters-to-be from some top drugmakers. Yet this year, Celgene, GlaxoSmithKline, Allergan and Novartis have big rollouts pending, a new report from OptumRx shows.
The list challenges a narrative that the pharma industry is shifting toward more targeted treatments. Drugmakers have put more focus on targeted cancer meds and orphan drugs, but in its new "pipeline insights" report, OptumRx highlights drug candidates set to shake up the marketplace for some more common conditions, such as migraines.
Joining Rybelsus in OptumRx’s report are a blockbuster anemia candidate from Acceleron Pharma and Celgene; a long-acting HIV injection from GSK’s ViiV Healthcare; a wet age-related macular degeneration candidate from Novartis and a CGRP migraine medicine from Allergan.
First up, luspatercept. Acceleron and Celgene are anticipating a potential December approval for the candidate to treat anemia in patients with very low- to intermediate-risk myelodysplastic syndromes and beta-thalassemia. Currently, the conditions require regular blood transfusions, but trials showed luspatercept can help reduce patients' frequency of those transfusions.
Analysts expect the drug to generate peak sales of more than $2 billion, OptumRx notes, and it would be the first-ever treatment for beta thalassemia. As such, industry watchers expect it to carry a high price. But it'll face a quick challenge from bluebird bio's LentiGlobin, a gene therapy expected to win approval in 2020. The FDA is set to decide on luspatercept's beta-thalassemia indication this year and has an April 2020 target date for a decision on the myelodysplastic syndromes use.
The drug drew the interest of Bristol-Myers Squibb, which is set to swallow Celgene in a megamerger. Luspatercept represents a "high value near-term asset," BMS has said.
Next on the OptumRx list is the combo of cabotegravir and rilpivirine, which together form a long-acting HIV injection from GSK's ViiV Healthcare. Oftentimes, patients taking current daily oral options stop taking their drugs, so a long-acting treatment has the potential for both “improved patient satisfaction and medication adherence,” OptumRx says. The FDA is set to act on the combo as a monthly injection by Dec. 29. A phase 3 study showed the drug is effective as a two-month injection, so that use could also come down the road.
Regeneron, Bayer and Roche might want to keep an eye out for the next drug on the list. Novartis’ brolucizumab, a candidate to treat wet age-related macular degeneraton, could shake up the market following a potential approval next month. Regeneron and Bayer’s Eylea and Roche and Novartis’ Lucentis are the main drugs for the condition as of now, but Novartis’ candidate topped Eylea on some measures in a phase 3 test.
Regeneron generates critical Eylea sales in the U.S., while Bayer handles marketing for that med in Europe. Roche sells Lucentis in the U.S. Both Eylea and Lucentis face 2020 patent expirations, so biosimilars could eat away at pricing in the market as Novartis seeks to grow sales for brolucizumab. Nevertheless, analysts predict peak sales of more than $1 billion for the candidate and say the drug will top the market by 2026, according to OptumRx.
Rounding out the OptumRx list is Allergan’s ubrogepant, an oral CGRP candidate to treat migraines as they occur, compared with already approved CGRP drugs that are used to help prevent migraines. The med is expected to win approval before the end of the year. Currently, triptans are the most common migraine medicines and cost about $20 to $30 per month, OptumRx says, so "pricing is a concern" for Allergan's forthcoming drug.
As for Novo's Rybelsus, OptumRx predicts the med will be an attractive option for Type 2 diabetes patients who have resisted treatment with an injectable. The drug could drive overall diabetes costs upward as it gains uptake. Analysts see the drug generating more than $2 billion annually by 2024.
Previously, the OptumRx team has noticed an "increased focus" in orphan drugs, but several meds on the new list treat conditions affecting large numbers of patients. The new launches "take a different or novel approach to treatment" and will be attractive options for patients and doctors, OptumRx says; the team predicts there could be a "significant" shake-up in current markets.