AbbVie, Allergan, and Sanofi Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AbbVie, Allergan, Perrigo, Sanofi, and Teva.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday January 18, 2017 to Tuesday January 24, 2017.
FDA OKs AbbVie’s Cancer Drug for Rare Cancer Indication
The US Food and Drug Administration has approved AbbVie’s anti-cancer drug, Imbruvica (ibrutinib), for an additional rare-cancer indication. Imbruvica is now approved for treating patients with relapsed/refractory marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Imbruvica was first approved in November 2013 for treating mantle cell lymphoma (MCL). The drug is also now approved for treating MZL; other non-Hodgkin’s lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL); and Waldenström’s macroglobulinemia. Imbruvica is also approved for treating patients with previously treated CLL/SLL, in combination with bendamustine and rituximab.
Imbruvica is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. The drug is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, a Johnson & Johnson company.
Allergan Gets FDA Approval for Rosacea Cream
Allergan has received approval from the US Food and Drug Administration for Rhofade (oxymetazoline hydrochloride) cream, an alpha-1A andrenergic receptor agonist, for treating persistent redness in the face (facial erythema) associated with rosacea.
Rhofade will be available for commercial supply starting May 2017 in the US.
Perrigo Gets FDA OK for Generic Psoriasis Spray
Perrigo has received US Food and Drug Administration approval for its abbreviated new drug application referencing Taro Pharmaceuticals USA’s Topicort Spray, 0.25% (desoximetasone topical spray, 0.25%). Taro Pharmaceuticals USA is the Hawthorne, New York-based operating arm of Taro Pharmaceutical Industries, a research-based pharmaceutical company headquartered in Haifa Bay, Israel.
Prior patent litigation between Perrigo and Taro has been settled on confidential terms. Topicort Spray, 0.25% is a corticosteroid indicated for treating plaque psoriasis in patients 18 years of age and older.
Sanofi’s Diabetes Combo Drug Approved in Europe
Sanofi has been granted marketing authorization by the European Commission for its anti-diabetes combo regimen, Suliqua, a once-daily titratable fixed-ratio combination of basal insulin glargine 100 units/mL and lixisenatide, a glucagon-like peptide (GLP)-1 receptor agonist. Suliqua is indicated for treating Type 2 diabetes.
Suliqua has been authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose-lowering medicinal product or with basal insulin. Suliqua will be delivered in two prefilled SoloStar pens, providing different dosing options.
The differentiation between the pen strengths is based on the dose range and ratios of each pen. The 10–40 SoloStar prefilled pen will deliver 10 to 40 dose steps of insulin glargine 100 units/mL in combination with 5 to 20 micrograms of lixisenatide. The 30–60 SoloStar prefilled pen will deliver 30 to 60 dose steps of insulin glargine 100 units/mL in combination with 10 to 20 micrograms of lixisenatide.
Marketing authorization in Europe for Suliqua is applicable to the 28 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway. Suliqua was previously approved in the US by the Food and Drug Administration in November 2016 as Soliqua 100/33. The product was launched in the US market in early January 2017. Launches in individual EU countries are anticipated from the second quarter of 2017 and onward.
Teva Gets FDA OK for Abuse-Resistant Opioid
The US Food and Drug Administration has approved Teva Pharmaceutical Industries’ Vantrela ER (hydrocodone bitartrate) extended-release tablets, a Schedule II substance formulated with Teva’s proprietary abuse-deterrence technology.
Vantrela ER is indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Vantrela ER is not indicated as an as-needed analgesic.
Schedule II substances are substances that have a high potential for abuse, which may lead to severe psychological or physical dependence. Vantrela ER contains hydrocodone, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.
Source: Teva Pharmaceutical Industries
FDA OKs Synergy’s Constipation Drug
Synergy Pharmaceuticals, a New York-based biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for Trulance (plecanatide) for treating chronic idiopathic constipation (CIC).
Trulance is a guanylate cyclase-C agonist designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal peptide that is associated with regular bowel function. Trulance will be available in the US later in the first quarter of 2017.
With this approval, Trulance joins Allergan’s Linzess (linaclotide), approved in 2012 by the FDA for the same CIC indication. Linzess is currently approved for CIC and irritable bowel syndrome with constipation (IBS-C). Global sales for Allergan’s Linzess more than doubled to approximately $460 million in 2015 from $174 million in 2014.
In addition to Trulance’s CIC indication, Synergy has completed two Phase III clinical trials in IBS-C and plans to file a supplemental new drug application with that clinical data later in the first quarter of 2017.
Source: Synergy Pharmaceuticals