Mylan, Merck & Co., and Lilly Lead Drug Approval News

By Akia Thorpe -

December 6, 2017

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Mylan, Merck & Co., Lilly, and Amgen.

Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, November 29, 2017 to Tuesday, December 5, 2017.

FDA OKs Mylan's, Biocon's Biosimilar to Roche’s Herceptin
The US Food and Drug Administration has approved Ogivri (trastuzumab-dkst), a biosimilar to Roche’s Herceptin, from Mylan and Biocon, a Bangalore, India-based pharmaceutical company. Herceptin had 2016 global sales of CHF 6.78 billion ($7.03 billion).

Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for treating HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first biosimilar from Mylan and Biocon's joint portfolio approved in the US, according to Mylan. Mylan says it anticipates potentially being the first company to offer a biosimilar to Herceptin as a result of Mylan's ability to get global licenses for its trastuzumab product from Genentech and Roche earlier this year.

Biocon is partnered with Mylan for the development, manufacturing, supply, and commercialization of up to six proposed biosimilars, which includes trastuzumab, pegfilgrastim, and insulin analogs. Pegfilgrastim is the active ingredient in Amgen’s Neulasta, a leukocyte factor for treating neutropenia, or low white blood cell count, in patients with certain types of non-myeloid cancers. Neulasta is one of Amgen’s top-selling drugs with 2016 sales of $3.9 billion. The companies are also developing a biosimilar of Sanofi’s Lantus (insulin glargine), which had 2016 sales of EUR 5.71 billion ($6.54 billion).

Source: Mylan


Merck & Co. Gets FDA OK for Pediatric Use for HIV Drug Isentress
The US Food and Drug Administration (FDA) has approved a pediatric use for Merck & Co.’s Isentress (raltegravir), a integrase inhibitor, for use in combination with other antiretroviral agents, for treating HIV-1 in newborn patients from birth to four weeks of age weighing at least 2 kg.

Approved in 2007, Isentress is an integrase inhibitor developed for the treatment of HIV-1 infection. It is one of the regimen options recommended by the US Department of Health and Human Services, in combination with other antiretroviral agents, as a first-line therapy in treatment-naïve HIV-1 infected adults. Isentress, in combination with other antiretroviral agents, is also approved to treat HIV-1 infection in pediatric patients weighing at least 2 kg.

The drug is approved as part of combination therapy in 112 countries for treating HIV-1 infection in adult patients and adolescents. Isentress, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has been approved for use in 69 countries, and Isentress for oral suspension for infants at least four weeks of age is approved for use in 33 countries.

Source: Merck & Co.


FDA OKs New Use for Lilly's Arthritis Drug Taltz  
The US Food and Drug Administration (FDA) has approved a new use for Eli Lilly and Company’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis.

Taltz was first approved by the FDA in March 2016 for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor, according to Lilly.

Source: Eli Lilly and Company


FDA Approves New Use for Amgen's Cholesterol Drug Repatha
The US Food and Drug Administration (FDA) has approved a new indication for Amgen’s Repatha (evolocumab) to prevent heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease.

The FDA also approved Repatha to be used as an adjunct to diet, alone, or in combination with other lipid-lowering therapies, such as statins, for treating adults with primary hyperlipidemia to reduce low density lipoprotein cholesterol.

Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It was first approved in 2015 as a treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low density lipoprotein cholesterol.

Repatha is approved in more than 50 countries, including the US, Japan, Canada, and in all 28 countries that are members of the European Union. Applications in other countries are pending.

Source: Amgen