Pharma Industry Racing to Meet New Patent Goals through Accelerated Approvals for Breakthrough Therapies and Strategically Aligned Collaborations

Market Expertz   |     December 11, 2018


In general, the number of FDA approvals granted is a small fraction of the clinical lead compounds; but this year has been a very successful year for therapeutics development. In 2018, several top notch pharmaceutical companies and emerging players received approvals breakthrough therapies from FDA and other regulatory bodies, as a result of their continuous efforts for research and development for advanced therapeutics. In October 2018, Sanofi’s Dupixen received FDA approval for maintenance therapy in moderate-to-severe asthma patients over 12 years of age. In September 2018, Health Canada provided approval for Gilead Sciences’ Biktarvy, a integrase-inhibitor-based treatment for HIV.

Furthermore, among the wide range of therapeutic area, cancer remains the most focused area for drug development among emerging players as well as pharmaceutical giants. In December 2018, FDA provided accelerated approval for Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for initial treatment of metastatic non-squamous non-small cell lung cancer without EGFR/ALK genomic tumour aberrations. In November 2018, Pfizer received accelerated approval from FDA for its LORBRENA , for ALK-positive metastatic non-small cell lung cancer treatment; and its DAURISMO for treatment of newly-diagnosed acute myeloid leukemia in elderly over 75 years of age. In November 2018, Roche bagged accelerated approval from FDA for its Venclexta, in combination with a hypomethylating agent or low dose cytarabine, for newly-diagnosed acute myeloid leukaemia treatment in elderly. In February 2018, Johnson & Johnson’s Erleada, a next-generation androgen receptor inhibitor drug was approved by FDA for the treatment of non-metastatic castration-resistant prostate cancer.

In order to achieve innovation in therapeutics and fulfil unmet medical needs, various companies are undergoing strategically aligned mergers, partnerships and agreements with each other. In November 2018, Sanofi and Denali Therapeutics collaborated for the development of drugs for neurological and systemic inflammatory diseases, where Denali Therapeutics received upfront cash payment of USD 125 million from Sanofi. In October 2018, Pfizer established a clinical development agreement with Novartis for development of combination therapies for non-alcoholic steatohepatitis. In June 2018, Roche and Foundation Medicine entered into a merger for development in oncology genomic profiling and personalized medicine.

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