Editing Growth hormone (section)

==Drug development history==
{{Main|Growth hormone treatment#History}}
[[Genentech]] pioneered the use of [[recombinant DNA|recombinant]] human growth hormone for human therapy, which was approved by the FDA in 1985.{{cn|date=November 2024}}

Prior to its production by recombinant DNA technology, growth hormone used to treat deficiencies was extracted from the [[pituitary gland]]s of [[cadaver]]s.  Attempts to create a wholly synthetic HGH failed.  Limited supplies of HGH resulted in the restriction of HGH therapy to the treatment of idiopathic short stature.<ref name = "Maybe_1984">{{cite book | vauthors = Maybe NG | veditors = Bollon AP | title = Recombinant DNA products: insulin, interferon, and growth hormone | publisher = CRC Press | location = Boca Raton | year = 1984 | chapter = Direct expression of human growth in ''Escherichia coli'' with the lipoprotein promoter | isbn = 978-0-8493-5542-4 }}</ref>  Very limited clinical studies of growth hormone derived from an Old World monkey, the [[rhesus macaque]], were conducted by John C. Beck and colleagues in Montreal, in the late 1950s.<ref name="pmid13421688">{{cite journal | vauthors = Beck JC, Mcgarry EE, Dyrenfurth I, Venning EH | title = Metabolic effects of human and monkey growth hormone in man | journal = Science | volume = 125 | issue = 3253 | pages = 884–5 | date = May 1957 | pmid = 13421688 | doi = 10.1126/science.125.3253.884 | bibcode = 1957Sci...125..884B }}</ref> The study published in 1957, which was conducted on "a 13-year-old male with well-documented hypopituitarism secondary to a crainiophyaryngioma," found that: "Human and monkey growth hormone resulted in a significant enhancement of nitrogen storage&nbsp;... (and) there was a retention of potassium, phosphorus, calcium, and sodium.&nbsp;... There was a gain in body weight during both periods.&nbsp;... There was a significant increase in urinary excretion of aldosterone during both periods of administration of growth hormone. This was most marked with the human growth hormone.&nbsp;... Impairment of the glucose tolerance curve was evident after 10 days of administration of the human growth hormone. No change in glucose tolerance was demonstrable on the fifth day of administration of monkey growth hormone."<ref name="pmid13421688"/>  The other study, published in 1958, was conducted on six people: the same subject as the Science paper; an 18-year-old male with statural and sexual retardation and a skeletal age of between 13 and 14 years; a 15-year-old female with well-documented hypopituitarism secondary to a craniopharyngioma; a 53-year-old female with carcinoma of the breast and widespread skeletal metastases;  a 68-year-old female with advanced postmenopausal osteoporosis; and a healthy 24-year-old medical student without any clinical or laboratory evidence of systemic disease.<ref name="pmid13595475">{{cite journal | vauthors = Beck JC, McGARRY EE, Dyrenfurth I, Venning EH | title = The metabolic effects of human and monkey growth hormone in man | journal = Annals of Internal Medicine | volume = 49 | issue = 5 | pages = 1090–105 | date = November 1958 | pmid = 13595475 | doi = 10.7326/0003-4819-49-5-1090 }}</ref>

In 1985, unusual cases of [[Creutzfeldt–Jakob disease]] were found in individuals that had received cadaver-derived HGH ten to fifteen years previously.  Based on the assumption that infectious prions causing the disease were transferred along with the cadaver-derived HGH, cadaver-derived HGH was removed from the market.<ref name = "isbn0-07-144011-9"/>

In 1985, biosynthetic human growth hormone replaced pituitary-derived human growth hormone for therapeutic use in the U.S. and elsewhere.{{cn|date=November 2024}}

As of 2005, recombinant growth hormones available in the United States (and their manufacturers) included Nutropin ([[Genentech]]), Humatrope ([[Eli Lilly and Company|Lilly]]), Genotropin ([[Pfizer]]), Norditropin ([[Novo Nordisk|Novo]]),  and Saizen ([[Merck Serono]]). In 2006, the U.S. Food and Drug Administration (FDA) approved a version of [[rHGH]] called [[Omnitrope]] (Sandoz).<ref name="FDA_biosimilars">{{citation |url=https://www.fda.gov/ohrms/dockets/dockets/04P0231/04P-0231-pdn0001.pdf |title=FDA Response to three Citizen Petitions against biosimilars |work=FDA |date=30 May 2006 |access-date=23 November 2015}}</ref>  A sustained-release form of growth hormone, Nutropin Depot (Genentech and Alkermes) was approved by the FDA in 1999, allowing for fewer injections (every 2 or 4 weeks instead of daily); however, the product was discontinued by Genentech/Alkermes in 2004 for financial reasons (Nutropin Depot required significantly more resources to produce than the rest of the Nutropin line<ref> In 2023, the FDA approved a different sustained-release form of growth hormone, Sogroya® (somapacitan-beco) ([[Novo Nordisk|Novo]]) for both pediatric patients (2.5 years and older) and adult patients, whom have growth failure due to inadequate secretion of endogenous growth hormone (rHGH). Previously, the human growth hormone analog had only been approved for adult patients with growth hormone deficiency (AGHD). {{cite web | url = http://findarticles.com/p/articles/mi_m0EIN/is_2004_June_1/ai_n6050768 | title = Genentech and Alkermes Announce Decision to Discontinue Commercialization of Nutropin Depot | date = 2004-06-01 | work = Press Release | publisher =  Business Wire | access-date = 2011-08-28 }}</ref>).