Long but a worthy Read!25 Jan 2019 08:52
NEW YORK (Reuters) - The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday. And while oncology has been one of the hottest and most active therapeutic areas for drug development, drug-makers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.
Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines. Data from this new study appears to bear that out. “It ain’t getting any easier to develop new therapies.” said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15% chance of going from Phase I through to FDA approval, compared with a 7% the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12%, followed by endocrine system drugs, featuring diabetes treatments, at 10.4% and autoimmune diseases, such as rheumatoid arthritis, at 9.4%, the study found.
John Craighead, BIO’s Managing Director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established. “Phase II results are very predictive of the Phase III outcomes and very predictive of approval,” he said. Some 63% of drugs in Phase I testing advanced to Phase II, but only 33% of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision. Not surprisingly, the numbers increase greatly after that, as the drugs had already shown success in the clinic. Approval applications were filed for 55% of the drugs that made it to Phase III testing, and 80% of those gained eventual approval........may go some way to answering your question n4apenny??
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