Analysts at Thomson Reuters have issued a report detailing seven drugs that will likely hit blockbuster status this year—defined as earning more than $1 billion annually. These treatments are listed below.
Obeticholic Acid for Liver Disease
The farnesoid X receptor agonist obeticholic acid (Intercept Pharmaceuticals/Sumitomo Dainippon Pharma) is being developed for the potential oral treatment of chronic liver diseases. A new drug application was submitted in December 2014 for patients with primary biliary cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy in adults unable to tolerate UDCA. The Prescription Drug User Fee Act (PDUFA) date is May 29, 2016. If approved, obeticholic acid could become the first new treatment for PBC in more than two decades. Forecasts predict sales of $29 million in 2016, rising to $2.62 billion by 2020. Generic UDCA is the only other drug currently approved for the treatment of PBC.
Emtricitabine and Tenofovir for HIV-1 Infection
The nucleoside reverse transcriptase inhibitor tenofovir alafenamide fumarate (TAF, Gilead) is currently being developed as a component of several fixed-dose combinations, including the potential blockbuster regimen emtricitabine (another nucleoside reverse transcriptase inhibitor) plus tenofovir alafenamide (F/TAF). The F/TAF combo was submitted for FDA approval in April 2015 for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 12 years of age and older, in combination with other HIV antiretroviral agents. The FDA set a PDUFA date of April 7, 2016. If the treatment is approved, forecasts predict sales of $320 million in 2016, rising to $2.01 billion by 2020.
Rilpivirine/Emtricitabine/Tenofovir for HIV-1 Infection
Gilead is also developing rilpivirine (a non-nucleoside reverse transcriptase inhibitor) plus emtricitabine plus tenofovir alafenamide (R/F/TAF) for the potential treatment of patients with HIV-1 infection. A new drug application was submitted in July 2015, and a PDUFA date of March 1, 2016, has been set. If approved, forecasts predict R/F/TAF sales of $176 million in 2016, rising to $1.57 billion by 2020.
Grazoprevir and Elbasvir (Zepatier) for HCV Infection
Zepatier (MK-5172A, Merck) is an oral fixed-dose tablet formulation of the pan-genomic NS3/4A inhibitor grazoprevir and the NS5A inhibitor elbasvir. The product was approved by the FDA in January 2016 for the treatment of adults with chronic hepatitis C virus (HCV) genotype 1 or 4 infection, with or without ribavirin. Despite stiff competition from once-daily sofosbuvir/ledipasvir (Harvoni, Gilead) and twice-daily Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets, AbbVie). MK-5172A is expected to achieve sales of $636 million in 2016, rising to $1.54 billion by 2020.
Venetoclax for CLL
The second-generation BH3-mimetic venetoclax is being co-developed by AbbVie and Genentech as a potential oral treatment for cancer, primarily chronic lymphocytic leukemia (CLL). A new drug application was submitted for relapsed or refractory CLL with 17p deletion in November 2015. If venetoclax is approved, sales are forecast to be $168 million in 2016, rising to $1.48 billion by 2020, despite competition from ibrutinib (Imbruvica, Pharmacyclics/Janssen) and idelalisib (Zydelig, Gilead), which were approved in 2014.
Pimavanserin (Nuplazid) for Parkinson’s Psychosis
In November 2015, the FDA accepted a new drug application for pimavanserin (Nuplazid, Acadia Pharmaceuticals), a highly selective serotonin receptor agonist, for the treatment of Parkinson’s disease psychosis (PDP). This agent represents a potential new class of psychosis therapy and is expected to be the first drug approved in the U.S. for PDP. If cleared by the FDA, sales for pimavanserin are expected to grow from $74 million in 2016 to $1.41 billion in 2020.
Selexipag (Uptravi) for PAH
The non-prostanoid prostacyclin receptor agonist selexipag (Uptravi, Nippon Shinyaku/Actelion) was approved in December 2015 to delay disease progression and to reduce the risk of hospitalization in patients with pulmonary arterial hypertension (PAH). The product entered the U.S. market in the first week of January 2016. Competition is expected to come from riociguat (Adempas, Bayer Healthcare), a first-in-class soluble guanylate cyclase stimulator, and treprostinil (Orenitram, United Therapeutics), the only FDA-approved, orally administered prostacyclin analog. Sales for selexipag are forecast to increase from $189 million in 2016 to $1.268 billion by 2020.
Source: Thomson Reuters; February 2016.