Novartis, US WorldMeds, Amgen Lead Drug Approval News

By Akia Thorpe -

May 29, 2018

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis and Amgen.

Editor's Note: This article was updated on a continuous basis for news announced from Wednesday May 23, 2018 date to Tuesday May 29, 2018.

EC OKs Novartis' Sandoz' Biosimilar of J&J’s Blockbuster Drug Remicade
The European Commission (EC) has approved Zessly (infliximab), a biosimilar of Johnson & Johnson’s (J&J) Remicade (infliximab), an anti-inflammatory drug, from Novartis’ Sandoz. Remicade had 2017 global sales of $6.3 billion.

Zessly is designed to block the action of tumor necrosis factor (TNF)-alpha in patients with certain autoimmune diseases in which excess TNF-alpha activity may be harmful or cause onset of disease. The drug is approved for use in all indications of the reference medicine, including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Zessly is the sixth approved biosimilar medicine for Sandoz, with the company expecting several more oncology and immunology launches globally by 2020.

Other companies have also received approval for Remicade biosimilars. Hospira and Celltrion, an Incheon, South Korea-based life-sciences company, received European Union (EU) approval for Inflectra (infliximab), a Remicade biosimilar in September 2013. Pfizer later gained the biosimilar through its 2015 acquisition of Hospira. In 2009, Hospira and Celltrion formed a pact for developing biosimilars, including Inflectra. Pfizer holds exclusive commercialization rights to Inflectra in the US and certain other jurisdictions. The US Food and Drug Administration (FDA) later approved Inflectra from Pfizer/Hospira and Celltrion in April 2016.

In December 2017, the FDA approved another Remicade biosimilar from Pfizer, Ixifi (infliximab-qbtx) as for all eligible indications of the reference product. In February 2016, Sandoz acquired the rights for the development and commercialization of Ixifi in the European Economic Area, which includes the 28 member states of the European Union plus Iceland, Liechtenstein, and Norway. Sandoz acquired the rights to infliximab (i.e the active pharmaceutical ingredient in Ixifi) as part of Pfizer satisfying requirements from the European Commission to divest the product in connection with its acquisition of Hospira.

Merck & Co. and Samsung Bioepis, an Incheon, South Korea-headquartered biopharmaceutical company, received EU approval of Flixabi (infliximab-abda), another biosimilar of Remicade, in May 2016. In April 2017, the companies received US approval for their biosimilar, called Renflexis (infliximab-abda) in the US.

Source: Novartis


FDA OKs Non-Opioid Medicine for Opioid Withdrawal Symptoms
The US Food and Drug Administration (FDA) has approved a non-opioid medicine, Lucemyra (lofexidine hydrochloride), from US WorldMeds, a Louisville, Kentucky-headquartered specialty pharmaceutical company, for mitigating withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

Lucemyra may not completely prevent withdrawal symptoms and is only approved for treatment for up to 14 days, according to information from the FDA. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD, according to information from the FDA.

Opioid withdrawal includes symptom, such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea, and drug craving, which occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids, according to information from the FDA.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that is designed to reduce the release of norepinephrine. The actions of norepinephrine in the autonomic nervous system are believed to play a role in many of the symptoms of opioid withdrawal, according to information from the FDA.

Source: FDA


FDA Approves Amgen’s Prolia For New Use in Osteoporosis
The US Food and Drug Administration (FDA) has approved a new use for Amgen’s Prolia (denosumab) for treating glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is approved and marketed in over 80 countries worldwide. Prolia is approved in the US for treating postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

In the US, Prolia is also approved for increasing bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia is also indicated  in the US as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

Source: Amgen