Roche's Hemlibra Receives FDA Approval for Label Expansion

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Roche RHHBY announced that the FDA has approved a label expansion of its hemophilia drug, Hemlibra.

The drug is now approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, aged new born and older, with haemophilia A without factor VIII inhibitors.

The drug was approved based on positive results from the phase III studies - HAVEN 3 and HAVEN 4. Data from the studies showed that Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis (primary endpoint) and across all other bleed-related endpoints in the HAVEN 3 study. It also led to a clinically meaningful control of bleeding in the HAVEN 4 study.

Per the company, Hemlibra is now the only prophylactic treatment for patients suffering from haemophilia A with or without factor VIII inhibitors that can be administered subcutaneously (under the skin) and at multiple dosing options (once weekly, every two weeks or every four weeks).

We note that Hemlibra was granted Breakthrough Therapy designation by the FDA for haemophilia A without factor VIII inhibitors. The drug was also granted Priority Review. Meanwhile, Roche's Marketing Authorisation Application (MAA) variation for haemophilia A without factor VIII inhibitors is under review by the European Medicines Agency (EMA). The company also plans to submit applications to regulatory authorities around the world.

We remind investors that the FDA approved Hemlibra in November 2017 for the treatment of adults and children suffering from haemophilia A with factor VIII inhibitors.

Apart from Hemlibra, Roche's hematology portfolio includes approved drugs like MabThera/Rituxan, Gazyva, Tecentriq, and Venclexta, in collaboration with AbbVie ABBV . The pipeline includes polatuzumab vedotin/RG7596 and a small molecule antagonist of MDM2 (idasanutlin/RG7388).

Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs, which include Herceptin, Perjeta and Kadcyla.

The company is making efforts to develop its portfolio beyond oncology into immunology and neuroscience. Roche has more than a dozen investigational medicines in clinical development for diseases like multiple sclerosis, Alzheimer`s disease, spinal muscular atrophy, Parkinson`s disease, Huntington`s disease and autism spectrum disorder.

Approval of new drugs and diagnostics tests, and label expansion of existing key drugs bode well for Roche, given its current challenges.

Year to date, shares of Roche have declined 0.1% against the industry 's growth of 11%. Roche's legacy drugs like Herceptin and MabThera are facing competition from biosimilars. Novartis NVS has already launched its biosimilar version of Rituxan/MabThera in Europe. Amgen AMGN too has got its biosimilar of Avastin.

Zacks Rank

Roche currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
Referenced Symbols: NVS , RHHBY , ABBV , AMGN

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