AbbVie, J&J, Gilead, and Teva Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Abbvie, J&J, Gilead, and Teva.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday, August 2, 2017 to Tuesday, August 8, 2017.

FDA Approves AbbVie’s Hepatitis C Drug…
The US Food and Drug Administration (FDA) has approved AbbVie’s Mavyret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes. Mavyret is an eight-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.

Approval of Mavyret follows an FDA-granted breakthrough therapy designation for treating genotype 1 HCV patients who were not cured with prior direct acting antiviral therapy as well as priority review by the FDA.

AbbVie’s pan-genotypic regimen was also recently granted marketing authorization by the European Commission. AbbVie’s treatment is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

Glecaprevir, one of the active ingredients in Mavyret, was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.

The product marks another entry in AbbVie’s hepatitis C franchise. It also has Viekira Pak, ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), co-packaged for oral use

Source: AbbVie

…And OKs New Use for AbbVie’s and J&J’s Cancer Drug
The US Food and Drug Administration (FDA) has approved AbbVie’s and Johnson & Johnson’s Imbruvica (ibrutinib) for treating adult patients with chronic graft-versus-host-disease (cGVHD), a potential consequence of stem-cell or bone marrow transplant, after failure of one or more lines of systemic therapy.

Imbruvica, a Bruton’s tyrosine kinase inhibitor, was jointly developed and is commercialized by Pharmacyclics LLC, a subsidiary of AbbVie, and Janssen Biotech, part of Johnson & Johnson.  AbbVie acquired Pharmacyclics in 2015 for $21 billion.

Imbruvica blocks signals that tell malignant B cells to multiply and spread uncontrollably, according to Abbvie. The therapy has been granted four breakthrough therapy designations from the FDA, including in cGVHD.

Imbruvica is approved for six indications overall, including adult patients with cGVHD that failed to respond to one or more lines of systemic therapy as well as adults with certain types of non-Hodgkin’s lymphomas, including CLL/small lymphocytic lymphoma, including patients with 17p deletion; patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; patients with Waldenström’s macroglobulinemia, a type of non-Hodgkin lymphoma; and patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for the MCL and MZL indications. Continued approval for the MCL and MZL indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Source: AbbVie and Johnson & Johnson

FDA Approves Celgene’s Oral Leukemia Therapy
The US Food and Drug Administration (FDA) has approved Idhifa (enasidenib) from Celgene and Agios Pharmaceuticals, a Cambridge, Massachusetts-headquartered biopharmaceutical company, for treating adult patients with relapsed or refractory acute myeloid leukemia (AML), a cancer of the myeloid line of blood cells (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a FDA-approved test.

Idhifa, an oral targeted inhibitor of the IDH2 enzyme, is a FDA-approved therapy for patients with R/R AML and an IDH2 mutation, which represents between 8% and 19% of AML patients, according to Celgene.

Source: Celgene  and Agios Pharmaceuticals

FDA OKs Jazz Pharmaceuticals’ Leukemia Drug
The US Food and Drug Administration (FDA) has approved Vyxeos (daunorubicin and cytarabine) liposome for injection from Jazz Pharmaceuticals’, a Dublin-Ireland-based biopharmaceutical company, for treating adults with two types of acute myeloid leukemia (AML), a blood cancer.  Vyxeos is indicated for treating adults with newly-diagnosed t-AML or AML-MRC.

Vyxeos is a liposomal formulation that is designed to deliver a fixed-ratio of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models, according to Jazz Pharmaceuticals.  Vyxeos is the first product developed with the company’s proprietary CombiPlex platform, a nano-scale, combination drug delivery technology platform for the development of cancer products.

The FDA granted the Vyxeos application priority review status, designated Vyxeos as a breakthrough therapy and also granted fast track designation.  Vyxeos received orphan drug designation by the FDA and the European Commission for treating AML.

Vyxeos will be commercially available in August 2017.

Source: Jazz Pharmaceuticals

FDA Approves Expanded Label for Hepatitis C Drug
The US Food and Drug Administration (FDA) has approved an updated labeling for Epclusa (sofosbuvir 400mg/velpatasvir 100mg) from Gilead Sciences as an all-oral, pan-genotypic, once-daily single tablet regimen for treating adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

In June 2016, Epclusa received regulatory approval in the US for treating adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.

Source: Gilead Sciences

FDA Gives Nod for Teva’s Inhalation Aerosol
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries’ Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy in patients four years of age and older.

The product is expected to become commercially available in both 40-mcg and 80-mcg strengths to patients by prescription during the first quarter of 2018.

QVAR RediHaler delivers medication via a breath-actuated metered dose inhaler (MDI) to remove the need for hand-breath coordination during inhalation. Qvar RediHaler administers the same active drug ingredient found in Teva’s Qvar Inhalation Aerosol, with a different mode of delivery.

Qvar MDI with dose counter, the currently available form of Qvar, was originally approved by the FDA in 2014. Teva plans to discontinue sales of this current Qvar MDI formulation upon the launch of Qvar RediHaler in the first quarter of 2018.

Source: Teva Pharmaceutical Industries

Mylan Receives Tentative Approval for HIV Drug
Mylan has received tentative approval from the US Food and Drug Administration under the US President’s Emergency Plan for AIDS Relief for its new drug application for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, 50 mg/300 mg/300 mg (TDF-3TC-DTG or TLD).

TLD, an antiretroviral fixed-dose combination, will be available in developing countries as a regimen for treating people with HIV/AIDS. Mylan’s TLD combines molecules from three originator medicines: ViiV Healthcare’s Tivicay (dolutegravir) (via a license through the Medicines Patent Pool, a United Nations’ public health organization) and Epivir (lamivudine) and Gilead Science’s Viread (tenofovir disoproxil fumarate).

Source: Mylan

EU Approves New Use for Bayer’s Cancer Drug
The European Commission (EC) has granted marketing authorization for Bayer’s Stivarga (regorafenib) for treating adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib).

Regorafenib is an oral multi-kinase inhibitor that blocks multiple protein kinases involved in tumor angiogenesis, oncogenesis, metastasis, and tumor immunity, according to Bayer.

This marks the third approval in five months for Stivarga, with the product also gaining approval in the US and Japan for second-line treatment of HCC in April and June, respectively.

Additional regulatory filings for Stivarga in HCC are under review in other countries around the world, including China. Stivarga is already approved in more than 90 countries worldwide, including the US, Japan, China and countries in the EU, for treating metastatic colorectal cancer (mCRC). Stivarga is also approved in more than 80 countries globally, including the US, Japan, China, and countries in the EU, for treating metastatic gastrointestinal stromal tumors.

In the EU, Stivarga is indicated as monotherapy for treating adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for treating adult patients with unresectable or metastatic gastrointestinal stromal tumor who progressed on or are intolerant to prior treatment with imatinib and sunitinib, and for treating adult patients with HCC who have been previously treated with sorafenib.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

Source: Bayer


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