AbbVie, Novartis, and Roche Lead Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AbbVie, Novartis, and Roche.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday December 7.2016 to Tuesday December 13,2016.

AbbVie Gets Conditional OK from EC for Leukemia Drug
AbbVie has received a conditional marketing authorization from the European Commission (EC) for Venclyxto (venetoclax) monotherapy for treating chronic lymphocytic leukaemia (CLL).

The indication is for treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

The EC approved Venclyxto as an oral, once-daily medicine that selectively inhibits the function of the B-cell lymphoma-2 (BCL-2) protein. BCL-2 prevents the natural death of cells, including CLL cells, according to AbbVie. Venclyxto is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the US and by AbbVie outside of the US.

Conditional marketing authorization is granted to medicines that address an unmet medical need, where the benefit of its immediate availability to patients outweighs the risk of limited data availability, and where comprehensive data will be provided.

In October 2016, European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use granted a positive opinion for the conditional marketing authorization of Venclyxto. In addition, the EMA granted orphan drug designation to the drug for treating multiple myeloma and for diffuse large B-cell lymphoma. Previously, the EMA granted orphan drug designation to Venclyxto for treating CLL6 and for treating acute myeloid leukaemia.

In April 2016, the US Food and Drug Administration granted accelerated approval of Venclexta (venetoclax) tablets for treating patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Venetoclax is also currently approved in Argentina, Puerto Rico, and Canada. AbbVie, in collaboration with Roche and Genentech, is currently working with regulatory agencies around the world.

Source: AbbVie


Endo Launches Generic Version of Merck’s Anti-Cholesterol Drug
Endo International has launched, through its operating company, Par Pharmaceutical, ezetimibe 10 mg tablets, the generic version of Merck & Co.’s anti-cholesterol drug, Zetia (ezetimibe). Par Pharmaceutical markets and distributes the product in the US and is entitled to Hatch-Waxman generic marketing exclusivity based on the first-to-file abbreviated new drug application status of its licensing partner, Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mahway, New Jersey, with whom Par will share profits.
Zetia is indicated for use along with a healthy diet to reduce elevated low-density lipid cholesterol in patients with hyperlipidemia. US sales of the drug were approximately $2.614 billion for the 12 months ended September 30, 2016, according to QuintilesIMS data and as cited by Endo.

Source: Endo International


Novartis Gets New Indication for Eye-Disease Drug
Novartis has been granted an additional indication from the European Commission for the eye-disease drug, Lucentis (ranibizumab). The new indication is for treating patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia.

Lucentis is a blockbuster drug with total sales of $1.383 billion in the first nine months of 2016.

The approval is applicable to all 28 European member states, as well as Iceland, Liechtenstein, and Norway. It was based on the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), adopted in October 2016. Following this approval, Lucentis covers six indications in Europe.

Submissions for this indication have been filed in 11 other countries, including Switzerland, Australia, Indonesia, and Brazil.

Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A. It is licensed for the treatment of nAMD, and for the treatment of visual impairment due to CNV, diabetic macular edema, branch retinal vein occlusion, and centrail retinal vein occlusion. The indication for the treatment of visual impairment due to CNV includes secondary to pathologic myopia (PM) and CNV associated with causes other than nAMD or PM (approved in EMA only).

Lucentis is available in more than 110 countries and was developed by Genentech, a Roche Group company, and Novartis. Genentech has the commercial rights to Lucentis in the US, and Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech.

Source: Novartis


FDA OKs Specific Cancer Indication for Roche’s Avastin
Genentech, a member of the Roche Group, has received approval from the US Food and Drug Administration (FDA) for a specific cancer indication for Avastin (bevacizumab). Avastin is one of Roche’s top-selling drugs with 2015 global sales of CHF 6.684 billion ($6.495 billion).

The new indication is for the use of Avastin either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for treating patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Avastin in combination with chemotherapy for platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer was granted priority review by the FDA.

In November 2014, Avastin was approved in the US for treating women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy.

Avastin is indicated for the first or second line treatment of patients with metastatic colorectal cancer in combination with intravenous 5 fluorouracil–based chemotherapy. In combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy, Avastin is indicated for the second line treatment of patients with metastatic colorectal cancer who have progressed on a first line Avastin-containing regimen. Avastin is not indicated for adjuvant treatment of colon cancer.

Avastin in combination with carboplatin and paclitaxel chemotherapy is indicated for first line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small cell lung cancer. It is also indicated for treating metastatic renal cell carcinoma in combination with interferon alfa.

Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix.

Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments. Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is also now approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Source: Genentech

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